FDA 510(k) Application Details - K001329

Device Classification Name Set, Administration, Intravascular

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510(K) Number K001329
Device Name Set, Administration, Intravascular
Applicant LIFEMED OF CALIFORNIA
1216 SOUTH ALLEC ST.
ANAHEIM, CA 92805-6301 US
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Contact PATRICIA BRINKER
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 04/27/2000
Decision Date 02/14/2001
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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