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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 K012018
Device Name BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
Applicant
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact FRANK J FUCILE
Correspondent
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact FRANK J FUCILE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/28/2001
Decision Date 07/16/2002
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
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