FDA 510(k) Application Details - K023282

Device Classification Name Warmer, Irrigation Solution

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510(K) Number K023282
Device Name Warmer, Irrigation Solution
Applicant O.R. SOLUTIONS, INC.
3901 CENTERVIEW DR.
SUITE W
CHANTILLY, VA 20151-1689 US
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Contact STEVE HANNES
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Regulation Number 000.0000

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Classification Product Code LHC
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Date Received 10/01/2002
Decision Date 11/13/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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