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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 K960695
Device Name MODEL 200C ELECTROSURGICAL PROBE
Applicant
ZOMED INTL.
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact THOMAS C WEHMAN, PH.D.
Correspondent
ZOMED INTL.
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact THOMAS C WEHMAN, PH.D.
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/20/1996
Decision Date 04/30/1996
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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