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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
510(k) Number K111059
Device Name GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
Applicant
Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact LORRAINE CALZETTA
Correspondent
Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact LORRAINE CALZETTA
Regulation Number884.4150
Classification Product Code
HIN  
Date Received04/18/2011
Decision Date 09/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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