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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 K952072
Device Name ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE
Applicant
ZOMED INTL.
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact THOM WEHMAN
Correspondent
ZOMED INTL.
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact THOM WEHMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/02/1995
Decision Date 10/04/1995
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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