The following data is part of a premarket notification filed by Jon-ko Products, Inc. with the FDA for Orthodontic Elastomeric Separator Module.
| Device ID | K943418 |
| 510k Number | K943418 |
| Device Name: | ORTHODONTIC ELASTOMERIC SEPARATOR MODULE |
| Classification | Band, Elastic, Orthodontic |
| Applicant | JON-KO PRODUCTS, INC. 10250 CAMINO SANTA FE San Diego, CA 92121 |
| Contact | Stephen Marnella |
| Correspondent | Stephen Marnella JON-KO PRODUCTS, INC. 10250 CAMINO SANTA FE San Diego, CA 92121 |
| Product Code | ECI |
| 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 |