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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 K973618
Device Name SOMNOPLASTY SYSTEM
Applicant
Somnus Medical Technologies, Inc.
285 N. Wolfe Rd.
Sunnyvale,  CA  94086
Applicant Contact EVE CONNER
Correspondent
Somnus Medical Technologies, Inc.
285 N. Wolfe Rd.
Sunnyvale,  CA  94086
Correspondent Contact EVE CONNER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/1997
Decision Date 12/19/1997
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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