FDA 510(k) Application Details - K955634

Device Classification Name Valve, Non-Rebreathing

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510(K) Number K955634
Device Name Valve, Non-Rebreathing
Applicant BOSTON MEDICAL PRODUCTS, INC.
117 FLANDERS RD.
WESTBOROUGH, MA 01581 US
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Contact STUART K MONTGOMERY
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Regulation Number 868.5870

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Classification Product Code CBP
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Date Received 12/11/1995
Decision Date 06/10/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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