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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 K081766
Device Name PKS OMNI INSTRUMENT
Applicant
GYRUS-ACMI L.P.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact LORRAINE CALZETTA
Correspondent
GYRUS-ACMI L.P.
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact LORRAINE CALZETTA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/20/2008
Decision Date 08/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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