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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 K240258
Device Name Disposable Medical Face Mask (M643BE)
Applicant
Makrite Industries, Inc.
11f-5., #79, Sec.1, Xintai 5th Rd., Xizhi Dist.
New Taipei,  TW
Applicant Contact Bob Wen
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/31/2024
Decision Date 04/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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