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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K213092
Device Name Cellusheet, Cellufil
Applicant
Human Biosciences, Inc.
940 Clopper Rd.
Gaithersburg,  MD  20878
Applicant Contact Jigar Patel
Correspondent
Methodize
P.O. Box 463
Nevis,  MN  56467
Correspondent Contact Jack Slovick
Classification Product Code
KGN  
Date Received09/24/2021
Decision Date 12/15/2021
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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