TECNADYNE 20/20 FOG INHIBITOR KIT

Laparoscope, General & Plastic Surgery

TECNADYNE SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Tecnadyne Scientific, Inc. with the FDA for Tecnadyne 20/20 Fog Inhibitor Kit.

Pre-market Notification Details

Device IDK940431
510k NumberK940431
Device Name:TECNADYNE 20/20 FOG INHIBITOR KIT
ClassificationLaparoscope, General & Plastic Surgery
Applicant TECNADYNE SCIENTIFIC, INC. 546 1ST ST. Vero Beach,  FL  32962
ContactJohn R Garrett
CorrespondentJohn R Garrett
TECNADYNE SCIENTIFIC, INC. 546 1ST ST. Vero Beach,  FL  32962
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-31
Decision Date1994-04-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30680651501098 K940431 000

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