ENDOSCOPIC SURGICAL INSTRUMENTS

Laparoscope, General & Plastic Surgery

TNCO, INC.

The following data is part of a premarket notification filed by Tnco, Inc. with the FDA for Endoscopic Surgical Instruments.

Pre-market Notification Details

Device IDK940551
510k NumberK940551
Device Name:ENDOSCOPIC SURGICAL INSTRUMENTS
ClassificationLaparoscope, General & Plastic Surgery
Applicant TNCO, INC. 15 COLEBROOK BLVD. P.O. BOX 231 Whitman,  MA  02382
ContactKarin Dolan
CorrespondentKarin Dolan
TNCO, INC. 15 COLEBROOK BLVD. P.O. BOX 231 Whitman,  MA  02382
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-07
Decision Date1994-04-29

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