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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 K926389
Device Name SWEEN WOUND CARE-COLLAGEN WOUND DRESSING
Applicant
Sween Corp.
1940 Commerce Dr.
P.O. Box 8300
N. Mankato,  MN  56001
Applicant Contact ELLIOTT FARBER
Correspondent
Sween Corp.
1940 Commerce Dr.
P.O. Box 8300
N. Mankato,  MN  56001
Correspondent Contact ELLIOTT FARBER
Classification Product Code
MGQ  
Date Received12/22/1992
Decision Date 07/08/1993
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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