FDA 510(k) Application Details - K983631

Device Classification Name Valve, Non-Rebreathing

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510(K) Number K983631
Device Name Valve, Non-Rebreathing
Applicant INSTRUMENTATION INDUSTRIES, INC.
2990 INDUSTRIAL BLVD.
BETHEL PARK, PA 15102 US
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Contact EDWARD C HOREY, JR.
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Regulation Number 868.5870

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Classification Product Code CBP
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Date Received 10/15/1998
Decision Date 07/01/1999
Decision SESE - SUBST EQUIV
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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