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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 K936304
Device Name ELECTROSURGICAL PENCIL
Applicant
E & M Engineering, Inc.
2116 Dabney Rd.
Suite A-5
Richmond,  VA  23230
Applicant Contact WINNY CHOW
Correspondent
E & M Engineering, Inc.
2116 Dabney Rd.
Suite A-5
Richmond,  VA  23230
Correspondent Contact WINNY CHOW
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/20/1993
Decision Date 06/13/1994
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
Recalls CDRH Recalls
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