CPR EYE TRAY

Drape, Surgical

CUSTOM PACK RELIABILITY

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

Pre-market Notification Details

Device IDK960242
510k NumberK960242
Device Name:CPR EYE TRAY
ClassificationDrape, Surgical
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 CodeKKX  
Subsequent Product CodeHNM
Subsequent Product CodeHNN
Subsequent Product CodeHNR
Subsequent Product CodeHNY
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-16
Decision Date1996-03-12

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