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FDA 510(k) Application Details - K101348
Device Classification Name
Holding Chambers, Direct Patient Interface
More FDA Info for this Device
510(K) Number
K101348
Device Name
Holding Chambers, Direct Patient Interface
Applicant
AGAPLASTIC IND. COM. LTDA.
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
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Contact
MARIA F GRIFFIN
Other 510(k) Applications for this Contact
Regulation Number
868.5630
More FDA Info for this Regulation Number
Classification Product Code
NVP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/13/2010
Decision Date
04/29/2011
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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