FDA 510(k) Application Details - K000125

Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular

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510(K) Number K000125
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant CLINICAL PLASTIC PRODUCTS SA
154 VIA LAMPARA
RANCHO SANTA MARGARITA, CA 92688 US
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Contact SALVADORE F PALOMARES
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 01/18/2000
Decision Date 04/12/2000
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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