FDA 510(k) Application Details - K940832

Device Classification Name Set, Administration, Intravascular

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510(K) Number K940832
Device Name Set, Administration, Intravascular
Applicant SIERRA MEDICAL DEVICES
154 HUGHES RD., SUITE 7
GRASS VALLEY, CA 95945 US
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Contact JOHN T WRIGHT
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 02/23/1994
Decision Date 01/23/1996
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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