The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Anti-mist, Anti-fog Eyeglass & Dental.
| Device ID | K822711 |
| 510k Number | K822711 |
| Device Name: | ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL |
| Classification | Bougie, Urological |
| Applicant | PARKER LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FAX |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-07 |
| Decision Date | 1982-11-03 |