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FDA 510(k) Application Details - K113338
Device Classification Name
Compressor, Air, Portable
More FDA Info for this Device
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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More FDA Info for this Product Code
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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