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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K160271
Device Name N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
Applicant
San-M Package Co., Ltd.
1086-1 Ojiro
Shimada-City,  JP 428-8652
Applicant Contact Shogo Nagao
Correspondent
Globizz Corporation
1411 W 190th St. Toyota Plaza #200
Gardena,  CA  90248
Correspondent Contact Takahiro Haruyama
Regulation Number878.4040
Classification Product Code
MSH  
Date Received02/02/2016
Decision Date 07/15/2016
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
Predetermined Change
Control Plan Authorized		 No
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