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 |