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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 K955020
Device Name PENEVAC ABC HANDPIECE
Applicant
I.C Medical, Inc.
5170 W. Phelps Rd.
Suite D
Glendale,  AZ  85306
Applicant Contact KURT HASPER
Correspondent
I.C Medical, Inc.
5170 W. Phelps Rd.
Suite D
Glendale,  AZ  85306
Correspondent Contact KURT HASPER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/02/1995
Decision Date 04/09/1996
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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