IRRIGATION TRAY WITH PISTON SYRINGE

Syringe, Piston

TRINITY LABORATORIES, INC.

The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Irrigation Tray With Piston Syringe.

Pre-market Notification Details

Device IDK942221
510k NumberK942221
Device Name:IRRIGATION TRAY WITH PISTON SYRINGE
ClassificationSyringe, Piston
Applicant TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury,  MD  21801
ContactParth Basumallik
CorrespondentParth Basumallik
TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury,  MD  21801
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-06
Decision Date1994-08-05

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