The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Infection Control Goggle (tse Fong)/ster/non-ster.
| Device ID | K874296 |
| 510k Number | K874296 |
| Device Name: | INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER |
| Classification | Mask, Surgical |
| Applicant | ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
| Contact | John Floren |
| Correspondent | John Floren ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1988-01-07 |