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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Pediatric Open Hospital
510(k) Number K925530
Device Name INSTRUMENT WARMER
Applicant
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Applicant Contact MAUREEN G MCCABE
Correspondent
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Correspondent Contact MAUREEN G MCCABE
Regulation Number880.5140
Classification Product Code
FMS  
Date Received11/02/1992
Decision Date 06/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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