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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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More FDA Info for this Product Code
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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