The following data is part of a premarket notification filed by Jon-ko Products, Inc. with the FDA for Orthodonitc Elastomeric Sleeving.
| Device ID | K943421 |
| 510k Number | K943421 |
| Device Name: | ORTHODONITC ELASTOMERIC SLEEVING |
| Classification | Tube, Orthodontic |
| Applicant | JON-KO PRODUCTS, INC. 10250 CAMINO SANTA FE San Diego, CA 92121 |
| Contact | Stephen M Marnella |
| Correspondent | Stephen M Marnella JON-KO PRODUCTS, INC. 10250 CAMINO SANTA FE San Diego, CA 92121 |
| Product Code | DZD |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-15 |
| Decision Date | 1995-05-23 |