FDA 510(k) Application Details - K955476

Device Classification Name Dressing, Wound And Burn, Occlusive

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510(K) Number K955476
Device Name Dressing, Wound And Burn, Occlusive
Applicant DUKAL CORP.
1247 FLORIDA AVE.
PALM HARBOR, FL 34683 US
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Contact PAT LAMB
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Regulation Number 000.0000

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Classification Product Code MGP
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Date Received 11/30/1995
Decision Date 01/18/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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