FDA 510(k) Application Details - K963623

Device Classification Name Dressing, Wound And Burn, Occlusive

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510(K) Number K963623
Device Name Dressing, Wound And Burn, Occlusive
Applicant POLYMEDICA INDUSTRIES, INC.
581 CONFERENCE PL.
GOLDEN, CO 80401 US
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Contact ANDREW M REED
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Regulation Number 000.0000

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Classification Product Code MGP
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Date Received 09/11/1996
Decision Date 10/25/1996
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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