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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 K203012
Device Name Surgical Mask
Applicant
Customfab, INC.
7345 Orangewood Ave
Garden Grove,  CA  92841
Applicant Contact Erentia Gillmer
Correspondent
Lean RAQA, LLCX
12602 N Summer Wind Drive
Marana,  AZ  85658
Correspondent Contact Laura Nygard
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/01/2020
Decision Date 04/11/2021
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
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