The following data is part of a premarket notification filed by Shuenn Bao Shing Corporation with the FDA for N95 Surgical Respirator, Type Ap0018 And Ap0028.
| Device ID | K072067 |
| 510k Number | K072067 |
| Device Name: | N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 |
| Classification | Respirator, Surgical |
| Applicant | SHUENN BAO SHING CORPORATION NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen SHUENN BAO SHING CORPORATION NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-27 |
| Decision Date | 2008-01-08 |
| Summary: | summary |