O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE

General Surgery Tray

TRINITY LABORATORIES, INC.

The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for O.r. Scrub Prep Tray, Sterile, Disposable.

Pre-market Notification Details

Device IDK965201
510k NumberK965201
Device Name:O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
ClassificationGeneral Surgery Tray
Applicant TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury,  MD  21801
ContactPartha Basumallik
CorrespondentPartha Basumallik
TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury,  MD  21801
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-26
Decision Date1997-02-14

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