FDA 510(k) Application Details - K912577

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K912577
Device Name Filter, Bacterial, Breathing-Circuit
Applicant VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA, NJ US
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Contact DENNIS IRLBECK
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 06/12/1991
Decision Date 04/22/1992
Decision SE - Substantially Equivalent
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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