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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 K962692
Device Name ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE
Applicant
Zomed Intl.
967 N. Shoreline Blvd.
Mountain View,  CA  94043
Applicant Contact THOMAS C WEHMAN, PH.D.,CQE, CQA
Correspondent
Zomed Intl.
967 N. Shoreline Blvd.
Mountain View,  CA  94043
Correspondent Contact THOMAS C WEHMAN, PH.D.,CQE, CQA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/11/1996
Decision Date 09/19/1996
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
Predetermined Change
Control Plan Authorized		 No
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