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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K100896
Device Name GYRUS ACMI HALO PKS CUTTING FORCEPS
Applicant
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact LORRAINE CALZETTA
Correspondent
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact LORRAINE CALZETTA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/31/2010
Decision Date 06/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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