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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 K951417
Device Name CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS
Applicant
Carrington Laboratories, Inc.
P.O. Box 168128
Irving,  TX  75061
Applicant Contact DENNIS R SPARKMAN
Correspondent
Carrington Laboratories, Inc.
P.O. Box 168128
Irving,  TX  75061
Correspondent Contact DENNIS R SPARKMAN
Classification Product Code
MGQ  
Date Received03/28/1995
Decision Date 05/10/1995
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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