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FDA 510(k) Application Details - K112271
Device Classification Name
Ventilator, Non-Continuous (Respirator)
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510(K) Number
K112271
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
3B PRODUCTS, LLC
1142 N SCENIC HIGHWAY
LAKE WALES, FL 33853 US
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Contact
ALEX LUCIO
Other 510(k) Applications for this Contact
Regulation Number
868.5905
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Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
08/08/2011
Decision Date
02/16/2012
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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