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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K212366
Device Name Heartland Health Surgical Mask
Applicant
Heartland Health Products
5389 E. Provident Dr.
Cincinnati,  OH  45246
Applicant Contact Frank Fischer
Correspondent
Heartland Health Products
5389 E. Provident Dr.
Cincinnati,  OH  45246
Correspondent Contact Frank Fischer
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/30/2021
Decision Date 02/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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