FDA 510(k) Application Details - K982587

Device Classification Name Set, Administration, Intravascular

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510(K) Number K982587
Device Name Set, Administration, Intravascular
Applicant MEDICAL PRODUCT SPECIALISTS
499 NIBUS ST., SUITE E
BREA, CA 92821 US
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Contact DAN HYUN
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 07/24/1998
Decision Date 08/24/1998
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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