FDA 510(k) Application Details - K952750

Device Classification Name Condenser, Heat And Moisture (Artificial Nose)

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510(K) Number K952750
Device Name Condenser, Heat And Moisture (Artificial Nose)
Applicant GIBECK, INC.
10640 EAST 59TH ST.
P.O. BOX 36430
INDIANAPOLIS, IN US
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Contact BRIAN GRIGSBY
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Regulation Number 868.5375

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Classification Product Code BYD
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Date Received 06/15/1995
Decision Date 07/20/1995
Decision SE - Substantially Equivalent
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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