GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)

Coagulator-cutter, Endoscopic, Bipolar (and Accessories)

GYRUS ACMI, INC.

The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmil Bipolarlaproscopic Loop (pks Bill).

Pre-market Notification Details

Device IDK111059
510k NumberK111059
Device Name:GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
ClassificationCoagulator-cutter, Endoscopic, Bipolar (and Accessories)
Applicant GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
ContactLorraine Calzetta
CorrespondentLorraine Calzetta
GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
Product CodeHIN  
CFR Regulation Number884.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-18
Decision Date2011-09-01
Summary:summary

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