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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 K223270
Device Name POSE™ Health Care Surgical Mask
Applicant
America's Supply Chains
7555 Warren Pkwy, Unit 486
Frisco,  TX  75034
Applicant Contact Paul Park
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/24/2022
Decision Date 11/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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