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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 K212521
Device Name Field Shield Wound Dressing
Applicant
Kericure, Inc.
26620 Easy St.
Wesley Chapel,  FL  33544
Applicant Contact Kerriann Greenhalgh
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Mehdi Kazemzadeh-Narbat
Classification Product Code
FRO  
Date Received08/10/2021
Decision Date 07/18/2024
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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