FDA 510(k) Application Details - K011937

Device Classification Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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510(K) Number K011937
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE, CA 92618 US
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Contact EBEN GORDON
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 06/21/2001
Decision Date 08/28/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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