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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 K983042
Device Name SWEEN WOUN'DRES
Applicant
Coloplast Corp.
1940 Commerce Dr.
North Mankato,  MN  56003
Applicant Contact HARVEY M ARBIT
Correspondent
Coloplast Corp.
1940 Commerce Dr.
North Mankato,  MN  56003
Correspondent Contact HARVEY M ARBIT
Classification Product Code
MGQ  
Date Received08/31/1998
Decision Date 11/25/1998
Decision Substantially Equivalent (SESE)
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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