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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 K021288
Device Name ORS-1000LD
Applicant
O.R. Solutions, Inc.
3901 Centerview Dr.
Suite W
Chantilly,  VA  20151 -1689
Applicant Contact STEVE HANNES
Correspondent
O.R. Solutions, Inc.
3901 Centerview Dr.
Suite W
Chantilly,  VA  20151 -1689
Correspondent Contact STEVE HANNES
Regulation Number890.5950
Classification Product Code
LHC  
Date Received04/23/2002
Decision Date 06/27/2002
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
Recalls CDRH Recalls
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