CPR TOTAL HIP PACK

Wrap, Sterilization

CUSTOM PACK RELIABILITY

The following data is part of a premarket notification filed by Custom Pack Reliability with the FDA for Cpr Total Hip Pack.

Pre-market Notification Details

Device IDK960213
510k NumberK960213
Device Name:CPR TOTAL HIP PACK
ClassificationWrap, Sterilization
Applicant CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando,  FL  32811
ContactRichard L Ellwood
CorrespondentRichard L Ellwood
CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando,  FL  32811
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-16
Decision Date1996-04-12

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