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FDA 510(k), K083621, MEDPOR CUSTOMIZED SURGICAL IMPLANT
FDA 510(k), K083621, MEDPOR CUSTOMIZED SURGICAL IMPLANT
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510(K) Number: K083621
Device Name: MEDPOR CUSTOMIZED SURGICAL IMPLANT
Manufacturer: POREX SURGICAL, INC.
Device Classification Name: polymer, ent synthetic, porous polyethylene
Regulation Number: 874.3620
Classification Product Code: JOF
Date Received: 12/08/2008
Decision Date: 02/03/2009
Regulation Medical Specialty: Ear Nose & Throat
Device Name: MEDPOR CUSTOMIZED SURGICAL IMPLANT
Manufacturer: POREX SURGICAL, INC.
Device Classification Name: polymer, ent synthetic, porous polyethylene
Regulation Number: 874.3620
Classification Product Code: JOF
Date Received: 12/08/2008
Decision Date: 02/03/2009
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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