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FDA 510(k) Application Details - K983736
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K983736
Device Name
Nebulizer (Direct Patient Interface)
Applicant
BRASAMERICA MEDICAL EQUIPMENT, INC.
55 NORTHERN BLVD., SUITE 410
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
868.5630
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Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
10/22/1998
Decision Date
11/10/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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