The following data is part of a premarket notification filed by Nbc Meshtec Inc. with the FDA for Cufitec Surgical Mask.
| Device ID | K182766 |
| 510k Number | K182766 |
| Device Name: | Cufitec Surgical Mask |
| Classification | Surgical Mask With Antimicrobial/antiviral Agent |
| Applicant | NBC Meshtec Inc. 2-50-3 Toyoda Hino, JP 191-0053 |
| Contact | Tomokazu Nagao |
| Correspondent | Takahiro Haruyama Globizz Corporation 1411 W. 190th St. Suite 200 Gardena, CA 90248 |
| Product Code | OUK |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006561826 | K182766 | 000 |