FDA 510(k) Application Details - K962218

Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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510(K) Number K962218
Device Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant CARRINGTON LABORATORIES, INC.
1300 EAST ROCHELLE BLVD.
IRVING, TX 75062 US
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Contact DENNIS R SPARKMAN, PH.D.
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Regulation Number 000.0000

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Classification Product Code MGQ
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Date Received 06/10/1996
Decision Date 09/12/1996
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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