FDA 510(k) Application Details - K945543

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K945543
Device Name Filter, Bacterial, Breathing-Circuit
Applicant INTERSECT MEDICAL PRODUCTS, INC.
4503 MOORLAND AVE.
MINNEAPOLIS, MN US
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Contact JEFFREY R SHIDEMAN
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 11/14/1994
Decision Date 11/29/1994
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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