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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K915002
Device Name STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESS
Applicant
Carrington Laboratories, Inc.
Post Box 569003
Dallas,  TX  75356
Applicant Contact ERIC MOORE
Correspondent
Carrington Laboratories, Inc.
Post Box 569003
Dallas,  TX  75356
Correspondent Contact ERIC MOORE
Classification Product Code
MGQ  
Date Received11/07/1991
Decision Date 01/31/1992
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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