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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 K863701
Device Name MODEL 709 BIPOLAR MICRO COAGULATOR
Applicant
Bergen Mfg.
5461 Decubellis Rd.
New Port Richey,  FL  33553
Applicant Contact ROGER L OOSTEN
Correspondent
Bergen Mfg.
5461 Decubellis Rd.
New Port Richey,  FL  33553
Correspondent Contact ROGER L OOSTEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/1986
Decision Date 10/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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