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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 K142289
Device Name PK Spatula
Applicant
Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact Neil Kelly
Correspondent
Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact Neil Kelly
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/18/2014
Decision Date 12/31/2014
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
Predetermined Change
Control Plan Authorized		 No
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