FDA 510(k) Application Details - K113338

Device Classification Name Compressor, Air, Portable

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510(K) Number K113338
Device Name Compressor, Air, Portable
Applicant ORICARE, INC.
1900 AM DRIVE
QUAKERTOWN, PA 18951 US
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Contact DAVID JAMISON
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Regulation Number 868.6250

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Classification Product Code BTI
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Date Received 11/14/2011
Decision Date 08/10/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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