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.
| Device ID | K160271 |
| 510k Number | K160271 |
| Device Name: | N95 Particulate Respirator And Surgical Mask, Models TN01-11 And TN01-12 |
| Classification | Respirator, 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 | MSH |
| 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 | 2016-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20386120010858 | K160271 | 000 |
| 20386120010841 | K160271 | 000 |