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FDA 510(k), K163645, DERMABOND PRINEO Skin Closure System
FDA 510(k), K163645, DERMABOND PRINEO Skin Closure System
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510(K) Number: K163645
Device Name: DERMABOND PRINEO Skin Closure System
Manufacturer: Joice Pappan
Device Classification Name: Cutaneous Tissue Adhesive With Mesh
Regulation Number: OMD
Classification Product Code: KXA
Date Received: 12/23/2016
Decision Date: 04/21/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: DERMABOND PRINEO Skin Closure System
Manufacturer: Joice Pappan
Device Classification Name: Cutaneous Tissue Adhesive With Mesh
Regulation Number: OMD
Classification Product Code: KXA
Date Received: 12/23/2016
Decision Date: 04/21/2017
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
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