FDA 510(k) Application Details - K960431

Device Classification Name Set, Administration, Intravascular

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510(K) Number K960431
Device Name Set, Administration, Intravascular
Applicant SCIENTIFIC DEVICE MANUFACTURER LLC.
999 ANDERSEN DRIVE, SUITE 120
SAN RAFAEL, CA 94901 US
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Contact RICHARD C BALL
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 01/31/1996
Decision Date 10/29/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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