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Full 510(k) File – K231325 (Complete Premarket Notification)
Full 510(k) File – K231325 (Complete Premarket Notification)
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510(K) Number: K231325
Device Name: Corplex P / Theracor P / Allacor P
Manufacturer: StimLabs, LLC
Device Classification Name: Wound Dressing With Animal-Derived Material(S)
Regulation Number:
Classification Product Code: KGN
Date Received: 05/08/2023
Decision Date: 02/02/2024
Regulation Medical Specialty:
Request Contents: Entire 510(k) file for K231325, including all sections of the premarket notification: 510(k) summary, device description, executive summary and predicate comparison, performance testing (animal, clinical, bench), biocompatibility, sterilization and shelf life, labeling, indications for use, validations, packaging, substantial equivalence.
Device Name: Corplex P / Theracor P / Allacor P
Manufacturer: StimLabs, LLC
Device Classification Name: Wound Dressing With Animal-Derived Material(S)
Regulation Number:
Classification Product Code: KGN
Date Received: 05/08/2023
Decision Date: 02/02/2024
Regulation Medical Specialty:
Request Contents: Entire 510(k) file for K231325, including all sections of the premarket notification: 510(k) summary, device description, executive summary and predicate comparison, performance testing (animal, clinical, bench), biocompatibility, sterilization and shelf life, labeling, indications for use, validations, packaging, substantial equivalence.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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