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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, Drug
510(k) Number K100218
Device Name BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
Applicant
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact REBEKA STOLTMAN
Correspondent
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact REBEKA STOLTMAN
Classification Product Code
FRO  
Date Received01/26/2010
Decision Date 02/17/2010
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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