The following data is part of a premarket notification filed by Berkley Medical Resources, Inc. with the FDA for 2505 Face Mask, Tie String / Anti-fog / Face Shield.
| Device ID | K962286 |
| 510k Number | K962286 |
| Device Name: | 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD |
| Classification | Mask, Surgical |
| Applicant | BERKLEY MEDICAL RESOURCES, INC. 49 VIRGINIA AVE. Uniontown, PA 15401 |
| Contact | Paul Zellner |
| Correspondent | Paul Zellner BERKLEY MEDICAL RESOURCES, INC. 49 VIRGINIA AVE. Uniontown, PA 15401 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-14 |
| Decision Date | 1996-10-07 |