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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 K964736
Device Name BERGEN 610 BIPOLAR COAGULATOR
Applicant
Bergen Mfg.
9345 Rookery Rd.
New Port Richey,  FL  34654
Applicant Contact ROGER OOSTEN
Correspondent
Bergen Mfg.
9345 Rookery Rd.
New Port Richey,  FL  34654
Correspondent Contact ROGER OOSTEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/25/1996
Decision Date 02/27/1997
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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