ARJORAD STERILE WRAP

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 Arjorad Sterile Wrap.

Pre-market Notification Details

Device IDK110954
510k NumberK110954
Device Name:ARJORAD STERILE WRAP
ClassificationWrap, Sterilization
Applicant ARJO WIGGINS MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach,  FL  33572
ContactJon Ward
CorrespondentJon Ward
ARJO WIGGINS MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach,  FL  33572
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-05
Decision Date2012-08-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815588021145 K110954 000
00815588020841 K110954 000
00815588020865 K110954 000
00815588020889 K110954 000
00815588020902 K110954 000
00815588020926 K110954 000
00815588020933 K110954 000
00815588020957 K110954 000
00815588020971 K110954 000
00815588020995 K110954 000
00815588021015 K110954 000
00815588021084 K110954 000
00815588021107 K110954 000
00815588021121 K110954 000
00815588020827 K110954 000

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