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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 K211440
Device Name ASM-301 Level 3 Surgical Mask
Applicant
American Surgical Mask Company LLC
5508 N 50th Street Suite 1000
tampa,  FL  33610
Applicant Contact matt brandman
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 Received05/10/2021
Decision Date 06/02/2021
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
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