YANKAUER WITH CONNECTING TUBING

Laparoscope, General & Plastic Surgery

TRINITY LABORATORIES, INC.

The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Yankauer With Connecting Tubing.

Pre-market Notification Details

Device IDK934750
510k NumberK934750
Device Name:YANKAUER WITH CONNECTING TUBING
ClassificationLaparoscope, General & Plastic Surgery
Applicant TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury,  MD  21801
ContactPartha Basumallik
CorrespondentPartha Basumallik
TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury,  MD  21801
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-04
Decision Date1994-02-17

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