S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable

Laparoscope, General & Plastic Surgery

Smith & Nephew

The following data is part of a premarket notification filed by Smith & Nephew with the FDA for S+n Laparoscopes, 4ko, Autoclavable, S+n Bariactric Laparoscopes, 4ko, Autoclavable.

Pre-market Notification Details

Device IDK201198
510k NumberK201198
Device Name:S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
ClassificationLaparoscope, General & Plastic Surgery
Applicant Smith & Nephew 150 Minuteman Rd Andover,  MA  01810
ContactJanice Haselton
CorrespondentJanice Haselton
Smith & Nephew 150 Minuteman Rd Andover,  MA  01810
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-04
Decision Date2020-07-17

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