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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Mask With Antimicrobial/Antiviral Agent
510(k) Number K182766
Device Name Cufitec Surgical Mask
Applicant
Nbc Meshtec, Inc.
2-50-3 Toyoda
Hino,  JP 191-0053
Applicant Contact Tomokazu Nagao
Correspondent
Globizz Corporation
1411 W. 190th St., Suite #200
Gardena,  CA  90248
Correspondent Contact Takahiro Haruyama
Regulation Number878.4040
Classification Product Code
OUK  
Date Received09/28/2018
Decision Date 01/03/2019
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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