PROXIDERM (TENTATIVE)

System, Skin Closure

PROGRESSIVE SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Progressive Surgical Products, Inc. with the FDA for Proxiderm (tentative).

Pre-market Notification Details

Device IDK942425
510k NumberK942425
Device Name:PROXIDERM (TENTATIVE)
ClassificationSystem, Skin Closure
Applicant PROGRESSIVE SURGICAL PRODUCTS, INC. 694 MAIN ST. Westbury,  NY  11590
ContactRobert Oddsen
CorrespondentRobert Oddsen
PROGRESSIVE SURGICAL PRODUCTS, INC. 694 MAIN ST. Westbury,  NY  11590
Product CodeMKY  
CFR Regulation Number878.4320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-20
Decision Date1994-11-04

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