The following data is part of a premarket notification filed by Professional Positioners, Inc. with the FDA for Soft-wear Headgear And Safety Modules.
| Device ID | K932761 |
| 510k Number | K932761 |
| Device Name: | SOFT-WEAR HEADGEAR AND SAFETY MODULES |
| Classification | Headgear, Extraoral, 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 | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-08 |
| Decision Date | 1993-10-07 |