The following data is part of a premarket notification filed by Professional Positioners, Inc. with the FDA for Pro's Neo-lastics.
| Device ID | K932298 |
| 510k Number | K932298 |
| Device Name: | PRO'S NEO-LASTICS |
| Classification | Band, Elastic, Orthodontic |
| Applicant | PROFESSIONAL POSITIONERS, INC. 2525 THREE MILE RD. Racine, WI 53404 |
| Contact | Sandra Ivanoski |
| Correspondent | Sandra Ivanoski PROFESSIONAL POSITIONERS, INC. 2525 THREE MILE RD. Racine, WI 53404 |
| Product Code | ECI |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-11 |
| Decision Date | 1994-02-14 |