FDA 510(k) Application Details - K070801

Device Classification Name Set, Administration, Intravascular

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510(K) Number K070801
Device Name Set, Administration, Intravascular
Applicant INNOVATIVE MEDICAL MANUFACTURING CO.
7128 STAFFORDSHIRE ST.
HOUSTON, TX 77030 US
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Contact JOSEPH J CHANG
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 03/23/2007
Decision Date 05/24/2007
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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