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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 K231953
Device Name Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)
Applicant
Coloplast Corp.
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact Laura Kelly
Correspondent
Coloplast Corp.
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact Laura Kelly
Classification Product Code
FRO  
Date Received06/30/2023
Decision Date 03/22/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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