PROXIDERM (D-460,D 90 460,D 180,460, PS 460)

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 (d-460,d 90 460,d 180,460, Ps 460).

Pre-market Notification Details

Device IDK970439
510k NumberK970439
Device Name:PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
ClassificationSystem, Skin Closure
Applicant PROGRESSIVE SURGICAL PRODUCTS, INC. 694 MAIN ST. Westbury,  NY  11590
ContactRobert Oddson
CorrespondentRobert Oddson
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 Received1997-02-05
Decision Date1997-04-16

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