The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene President Jet Regular Body.
| Device ID | K882800 |
| 510k Number | K882800 |
| Device Name: | COLTENE PRESIDENT JET REGULAR BODY |
| Classification | Material, Impression |
| Applicant | COLTENE, INC. 5205 AVENIDA ENCLINAS Carlsbao, CA 92008 |
| Contact | James K Shuck |
| Correspondent | James K Shuck COLTENE, INC. 5205 AVENIDA ENCLINAS Carlsbao, CA 92008 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-07 |
| Decision Date | 1988-09-23 |