CPR HEART PACK

Suture, Nonabsorbable, Synthetic, Polypropylene

CUSTOM PACK RELIABILITY

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

Pre-market Notification Details

Device IDK960209
510k NumberK960209
Device Name:CPR HEART PACK
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
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 CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-16
Decision Date1996-04-04

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