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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Electrosurgical
510(k) Number K945861
Device Name BERGEN 710 ESU
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
HAM  
Date Received12/01/1994
Decision Date 03/01/1995
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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