FDA 510(k) Application Details - K991225

Device Classification Name Syringe, Piston

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510(K) Number K991225
Device Name Syringe, Piston
Applicant MICRO THERAPEUTICS, INC.
1062-F CALLE NEGOCIO
SAN CLEMENTE, CA 92673 US
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Contact MARIA D OCHOA
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 04/12/1999
Decision Date 07/08/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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