FDA 510(k) Application Details - K955149

Device Classification Name Tube, Aspirating, Flexible, Connecting

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510(K) Number K955149
Device Name Tube, Aspirating, Flexible, Connecting
Applicant BIO-MEDICAL DEVICES, INC.
1752-A LANGLEY AVE.
IRVINE, CA 92614 US
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Contact NICK HERBERT
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Regulation Number 880.6740

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Classification Product Code BYY
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Date Received 11/13/1995
Decision Date 01/24/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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