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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 K850668
Device Name ELECTROSURGICAL UNIT 774
Applicant
BIRTCHER CORP.
4501 N. ARDEN DR.
P.O. BOX 4399
EL MONTE,  CA  91731
Applicant Contact VAN JARVIS
Correspondent
BIRTCHER CORP.
4501 N. ARDEN DR.
P.O. BOX 4399
EL MONTE,  CA  91731
Correspondent Contact VAN JARVIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/20/1985
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
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