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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K221048
Device Name Episealer Patellofemoral System
Applicant
Episurf Medical, Inc.
220 E 42nd St., Suite 409a
New York,  NY  10017
Applicant Contact Katarina Flodstrom
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Hollace Saas Rhodes
Regulation Number888.3540
Classification Product Code
KRR  
Date Received04/08/2022
Decision Date 12/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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