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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 K850297
Device Name ELECTROSURGICAL PENCIL HOLDER 720
Applicant
BIRTCHER CORP.
4501 N. ARDEN DR.
P.O. BOX 4399
EL MONTE,  CA  91731
Applicant Contact ENRIQUE RANGEL
Correspondent
BIRTCHER CORP.
4501 N. ARDEN DR.
P.O. BOX 4399
EL MONTE,  CA  91731
Correspondent Contact ENRIQUE RANGEL
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/24/1985
Decision Date 02/28/1985
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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