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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 K000720
Device Name SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE
Applicant
Somnus Medical Technologies, Inc.
285 N. Wolfe Rd.
Sunnyvale,  CA  94086
Applicant Contact STEVEN J OJALA
Correspondent
Somnus Medical Technologies, Inc.
285 N. Wolfe Rd.
Sunnyvale,  CA  94086
Correspondent Contact STEVEN J OJALA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/03/2000
Decision Date 05/30/2000
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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