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FDA 510(k), K142289, PK Spatula
FDA 510(k), K142289, PK Spatula
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510(K) Number: K142289
Device Name: PK Spatula
Manufacturer: Neil Kelly
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 08/18/2014
Decision Date: 12/31/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: PK Spatula
Manufacturer: Neil Kelly
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 08/18/2014
Decision Date: 12/31/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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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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