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FDA 510(k) Application Details - K962822
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K962822
Device Name
Nebulizer (Direct Patient Interface)
Applicant
HEALTHSCAN PRODUCTS, INC.
908 POMPTON AVE.
UNIT B2
CEDAR GROVE, NJ 07009-1292 US
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Contact
LAUREN R ZIEGLER
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
07/19/1996
Decision Date
10/17/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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