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FDA 510(k) Application Details - K022062
Device Classification Name
Accessory To Continuous Ventilator (Respirator)
More FDA Info for this Device
510(K) Number
K022062
Device Name
Accessory To Continuous Ventilator (Respirator)
Applicant
IMPACT INSTRUMENTATION, INC.
27 FAIRFIELD PL.
P.O. BOX 508
WEST CALDWELL, NJ 07006-0508 US
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Contact
LESLIE H SHERMAN
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
MOD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/25/2002
Decision Date
05/06/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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