MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL

Prosthesis, Chin, Internal

POREX SURGICAL, INC.

The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Barrier Surgical Implant Biomaterial.

Pre-market Notification Details

Device IDK952677
510k NumberK952677
Device Name:MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
ClassificationProsthesis, Chin, Internal
Applicant POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park,  GA  30349 -2417
ContactHoward Mercer
CorrespondentHoward Mercer
POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park,  GA  30349 -2417
Product CodeFWP  
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-12
Decision Date1995-08-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613252729860 K952677 000
07613252086093 K952677 000
07613252086086 K952677 000
07613252086048 K952677 000
07613252085805 K952677 000
07613252085799 K952677 000
07613252084914 K952677 000
07613252084907 K952677 000
07613252084723 K952677 000

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