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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 K161038
Device Name PK Morcellator
Applicant
GYRUS ACMI, INC.
136 TURNPIKE RD
SOUTHBOROUGH,  MA  02649
Applicant Contact GRAHAM A.L. BAILLIE
Correspondent
GYRUS ACMI, INC.
136 TURNPIKE RD
SOUTHBOROUGH,  MA  02649
Correspondent Contact GRAHAM A.L. BAILLIE
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HET  
Date Received04/13/2016
Decision Date 10/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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