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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 K963772
Device Name SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)
Applicant
Somnus Medical Technologies, Inc.
995 Benecia Ave.
Sunnyvale,  CA  94086
Applicant Contact EVA CONNER
Correspondent
Somnus Medical Technologies, Inc.
995 Benecia Ave.
Sunnyvale,  CA  94086
Correspondent Contact EVA CONNER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/19/1996
Decision Date 10/23/1996
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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