MITEK SNAP PAK(TM), MODIFICATION

Suture, Nonabsorbable, Synthetic, Polyester

MITEK SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Snap Pak(tm), Modification.

Pre-market Notification Details

Device IDK915081
510k NumberK915081
Device Name:MITEK SNAP PAK(TM), MODIFICATION
ClassificationSuture, Nonabsorbable, Synthetic, Polyester
Applicant MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood,  MA  02062
ContactRobert P Zoletti
CorrespondentRobert P Zoletti
MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood,  MA  02062
Product CodeGAS  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-12
Decision Date1992-01-31

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