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510(k) Complete Copy – StimLabs, LLC (K231325)
510(k) Complete Copy – StimLabs, LLC (K231325)
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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: Complete copy (releasable) of K231325, including any Additional Information (AI) requests and responses, and any other correspondence between StimLabs, LLC. and the FDA, including any releasable amendments.
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: Complete copy (releasable) of K231325, including any Additional Information (AI) requests and responses, and any other correspondence between StimLabs, LLC. and the FDA, including any releasable amendments.
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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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