ARJOWRAP 47/100 AND 47/88

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 Arjowrap 47/100 And 47/88.

Pre-market Notification Details

Device IDK062100
510k NumberK062100
Device Name:ARJOWRAP 47/100 AND 47/88
ClassificationWrap, Sterilization
Applicant ARJO WIGGINS MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach,  FL  33572
ContactArthur Ward
CorrespondentArthur Ward
ARJO WIGGINS MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach,  FL  33572
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-24
Decision Date2006-12-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00815588021169 K062100 000

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