INCISSION & DRAINAGE TRAY

Drape, Surgical

TRINITY LABORATORIES, INC.

The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Incission & Drainage Tray.

Pre-market Notification Details

Device IDK921203
510k NumberK921203
Device Name:INCISSION & DRAINAGE TRAY
ClassificationDrape, Surgical
Applicant TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury,  MD  21801
ContactPartha Basumallik
CorrespondentPartha Basumallik
TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury,  MD  21801
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-12
Decision Date1992-08-13

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