N95 Particulate Respirator And Surgical Mask, Models TN01-11 And TN01-12

Respirator, Surgical

SAN-M PACKAGE CO., LTD.

The following data is part of a premarket notification filed by San-m Package Co., Ltd. with the FDA for N95 Particulate Respirator And Surgical Mask, Models Tn01-11 And Tn01-12.

Pre-market Notification Details

Device IDK160271
510k NumberK160271
Device Name:N95 Particulate Respirator And Surgical Mask, Models TN01-11 And TN01-12
ClassificationRespirator, Surgical
Applicant SAN-M PACKAGE CO., LTD. 1086-1 OJIRO Shimada-city,  JP 428-8652
ContactShogo Nagao
CorrespondentTakahiro Haruyama
GLOBIZZ CORPORATION 1411 W. 190TH ST. TOYOTA PLAZA #200 Gardena,  CA  90248
Product CodeMSH  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-02
Decision Date2016-07-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20386120010858 K160271 000
20386120010841 K160271 000

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