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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Irrigation Solution
510(k) Number K880876
Device Name C-STAT/1000
Applicant
Sonne Medical, Inc.
805 Veterans Blvd., Suite 137
Redwood City,  CA  94063
Applicant Contact MD
Correspondent
Sonne Medical, Inc.
805 Veterans Blvd., Suite 137
Redwood City,  CA  94063
Correspondent Contact MD
Regulation Number890.5950
Classification Product Code
LHC  
Date Received03/01/1988
Decision Date 05/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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