The following data is part of a premarket notification filed by San-m Package Co., Ltd. with the FDA for Surgical Face Masks (ear Loops And Tie-on).
Device ID | K160269 |
510k Number | K160269 |
Device Name: | Surgical Face Masks (Ear Loops And Tie-on) |
Classification | Mask, Surgical |
Applicant | SAN-M PACKAGE CO., LTD. 1086-1 Ojiro Shimada-city, JP 428-8652 |
Contact | Shogo Nagao |
Correspondent | Takahiro Haruyama Globizz Corporation 1411 W. 190th St. Toyota Plaza #200 Gardena, CA 90248 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-02 |
Decision Date | 2016-09-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20386120010889 | K160269 | 000 |
20386120010865 | K160269 | 000 |
20386120010933 | K160269 | 000 |