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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 K921633
Device Name ORS-2000 SERIES
Applicant
Mnlase, Inc.
11250 Roger Bacon Dr. #10
Reston,  VA  22090
Applicant Contact BRUCE HEYMANN
Correspondent
Mnlase, Inc.
11250 Roger Bacon Dr. #10
Reston,  VA  22090
Correspondent Contact BRUCE HEYMANN
Regulation Number890.5950
Classification Product Code
LHC  
Date Received04/06/1992
Decision Date 06/02/1992
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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