The following data is part of a premarket notification filed by Nibec Co Ltd with the FDA for Guidoss.
| Device ID | K133507 |
| 510k Number | K133507 |
| Device Name: | GUIDOSS |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | NIBEC CO LTD 4568 W. 1ST STREET, STE 104 Los Angeles, CA 90004 |
| Contact | Daniel Nam |
| Correspondent | Daniel Nam NIBEC CO LTD 4568 W. 1ST STREET, STE 104 Los Angeles, CA 90004 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-14 |
| Decision Date | 2014-11-05 |
| Summary: | summary |