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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 K962218
Device Name CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
Applicant
Carrington Laboratories, Inc.
1300 E. Rochelle Blvd.
Irving,  TX  75062
Applicant Contact DENNIS R SPARKMAN, PH.D.
Correspondent
Carrington Laboratories, Inc.
1300 E. Rochelle Blvd.
Irving,  TX  75062
Correspondent Contact DENNIS R SPARKMAN, PH.D.
Classification Product Code
MGQ  
Date Received06/10/1996
Decision Date 09/12/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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