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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 K970576
Device Name SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)
Applicant
Somnus Medical Technologies, Inc.
285 N. Wolfe Rd.
Sunnyvale,  CA  94086
Applicant Contact EVE A CONNER, PH.D.
Correspondent
Somnus Medical Technologies, Inc.
285 N. Wolfe Rd.
Sunnyvale,  CA  94086
Correspondent Contact EVE A CONNER, PH.D.
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/13/1997
Decision Date 04/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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