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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 K850943
Device Name MODEL 775 BIPOLAR COAGULATOR
Applicant
Birtcher Corp.
4501 N. Arden Dr.
P.O. Box 4399
El Monte,  CA  91731
Applicant Contact DONALD L EMMONS
Correspondent
Birtcher Corp.
4501 N. Arden Dr.
P.O. Box 4399
El Monte,  CA  91731
Correspondent Contact DONALD L EMMONS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/07/1985
Decision Date 05/20/1985
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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