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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Dressing, Wound, Drug
510(k) Number K894541
Device Name CARRINGTON DERMAL WOUND GEL
Applicant
Carrington Laboratories, Inc.
9200 Carpenter Fwy.
Dallas,  TX  75247
Applicant Contact BILL H MCANALLEY
Correspondent
Carrington Laboratories, Inc.
9200 Carpenter Fwy.
Dallas,  TX  75247
Correspondent Contact BILL H MCANALLEY
Classification Product Code
FRO  
Date Received07/20/1989
Decision Date 11/30/1989
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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