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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 K931885
Device Name DRIGEL MULTIFUNCTION ELECTRODE
Applicant
Physiometrix, Inc.
575 N. Pastoria Ave.
Sunnyvale,  CA  94086
Applicant Contact Claire Andrews
Correspondent
Physiometrix, Inc.
575 N. Pastoria Ave.
Sunnyvale,  CA  94086
Correspondent Contact Claire Andrews
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/15/1993
Decision Date 09/09/1993
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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