FDA 510(k) Application Details - K960917

Device Classification Name Dilator, Vessel, For Percutaneous Catheterization

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510(K) Number K960917
Device Name Dilator, Vessel, For Percutaneous Catheterization
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 870.1310

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Classification Product Code DRE
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Date Received 03/06/1996
Decision Date 07/02/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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