STERILIZATION WRAP-STERISHEET

Wrap, Sterilization

ARJO WIGGINS MEDICAL, INC.

The following data is part of a premarket notification filed by Arjo Wiggins Medical, Inc. with the FDA for Sterilization Wrap-sterisheet.

Pre-market Notification Details

Device IDK931202
510k NumberK931202
Device Name:STERILIZATION WRAP-STERISHEET
ClassificationWrap, Sterilization
Applicant ARJO WIGGINS MEDICAL, INC. SUSAN B. HOWARD P.O. BOX 2010 Palm Harbor,  FL  34682
ContactR.m.s., Inc.
CorrespondentR.m.s., Inc.
ARJO WIGGINS MEDICAL, INC. SUSAN B. HOWARD P.O. BOX 2010 Palm Harbor,  FL  34682
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-09
Decision Date1993-12-16

NIH GUDID Devices

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