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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 K023283
Device Name 1075LD HUSH-SLUSH
Applicant
O.R. Solutions, Inc.
3901 Centerview Dr.
Suite W
Chantilly,  VA  20151
Applicant Contact STEVE HANNES
Correspondent
O.R. Solutions, Inc.
3901 Centerview Dr.
Suite W
Chantilly,  VA  20151
Correspondent Contact STEVE HANNES
Regulation Number890.5950
Classification Product Code
LHC  
Date Received10/01/2002
Decision Date 11/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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