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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
Device Name MEDICAL AIR COMPRESSOR
Applicant
ORICARE, INC.
1900 AM DRIVE
QUAKERTOWN,  PA  18951
Applicant Contact DAVID JAMISON
Correspondent
ORICARE, INC.
1900 AM DRIVE
QUAKERTOWN,  PA  18951
Correspondent Contact DAVID JAMISON
Regulation Number868.6250
Classification Product Code
BTI  
Date Received11/14/2011
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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