FDA 510(k) Application Details - K955008

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

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510(K) Number K955008
Device Name Condenser, Heat And Moisture (Artificial Nose)
Applicant INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS, FL 33905 US
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Contact AVIA TONEY
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Regulation Number 868.5375

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Classification Product Code BYD
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Date Received 11/01/1995
Decision Date 01/30/1996
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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