The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Kleenspec Disposable Face Shield, Model 57001.
| Device ID | K875194 |
| 510k Number | K875194 |
| Device Name: | KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001 |
| Classification | Mask, Surgical |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | John Watkins |
| Correspondent | John Watkins WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-17 |
| Decision Date | 1988-01-22 |