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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name compressor, air, portable
510(k) Number K113338
Model C4500
Device Name MEDICAL AIR COMPRESSOR
Original Applicant
ORICARE, INC.
1900 am drive
quakertown,  PA  18951
Original Contact david jamison
Regulation Number868.6250
Classification Product Code
BTI  
Date Received11/14/2011
Decision Date 08/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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