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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 K080093
FOIA Releasable 510(k) K080093
Device Name PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
Applicant
Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact TERRENCE E SULLIVAN
Correspondent
Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact TERRENCE E SULLIVAN
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HET  
Date Received01/14/2008
Decision Date 05/02/2008
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
Predetermined Change
Control Plan Authorized		 No
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