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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
Recalls CDRH Recalls
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