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FDA 510(k) Application Details - K981841
Device Classification Name
Cleaner, Air, Medical Recirculating
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510(K) Number
K981841
Device Name
Cleaner, Air, Medical Recirculating
Applicant
RESPIRAID LTD.
117 AHUZAH ST.
RA'ANANNA 43373 IL
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Contact
SHOSHANA FRIEDMAN
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Regulation Number
880.5045
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Classification Product Code
FRF
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More FDA Info for this Product Code
Date Received
05/26/1998
Decision Date
10/13/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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