MOUNTABLE ENDOSCOPIC BLADE

Knife, Surgical

A.M. SURGICAL, INC.

The following data is part of a premarket notification filed by A.m. Surgical, Inc. with the FDA for Mountable Endoscopic Blade.

Pre-market Notification Details

Device IDK080133
510k NumberK080133
Device Name:MOUNTABLE ENDOSCOPIC BLADE
ClassificationKnife, Surgical
Applicant A.M. SURGICAL, INC. 290 EAST MAIN ST. SUITE 200 Smithtown,  NY  11787
ContactVincent Pascale
CorrespondentVincent Pascale
A.M. SURGICAL, INC. 290 EAST MAIN ST. SUITE 200 Smithtown,  NY  11787
Product CodeEMF  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-18
Decision Date2008-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420193001 K080133 000
00840420192943 K080133 000

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