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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 K122605
Device Name PKS BILL
Applicant
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact NEIL KELLY
Correspondent
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact NEIL KELLY
Regulation Number884.4150
Classification Product Code
HIN  
Date Received08/27/2012
Decision Date 12/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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