FDA 510(k) Application Details - K022062

Device Classification Name Accessory To Continuous Ventilator (Respirator)

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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
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Regulation Number 868.5895

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Classification Product Code MOD
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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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