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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 K230383
Device Name Savvy Surgical Mask - Level 3
Applicant
ALG Health LLC
520 W Mulberry St
Bryan,  OH  43506
Applicant Contact Doug Soper
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 Received02/13/2023
Decision Date 03/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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