FDA 510(k) Application Details - K001508

Device Classification Name Dressing, Wound And Burn, Occlusive

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510(K) Number K001508
Device Name Dressing, Wound And Burn, Occlusive
Applicant FIDIA ADVANCED BIOPOLYMERS SRL
VIA PONTE DELLA FABBRICA,3/A
35031 ABANO TERME (PD) 35031 IT
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Contact PAOLO RAMPAZZO
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Regulation Number 000.0000

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Classification Product Code MGP
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Date Received 05/15/2000
Decision Date 07/25/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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