FDA 510(k) Application Details - K993187

Device Classification Name Set, Administration, Intravascular

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510(K) Number K993187
Device Name Set, Administration, Intravascular
Applicant DIASOL, INC.
13212 RAYMER ST.
NORTH HOLLYWOOD, CA 91605 US
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Contact MONICA ABELES
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 09/23/1999
Decision Date 11/05/1999
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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