The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Maximum Control Gown.
| Device ID | K874318 |
| 510k Number | K874318 |
| Device Name: | MAXIMUM CONTROL GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
| Contact | John W Floren |
| Correspondent | John W Floren ULTI-MED INTL., INC. 710 E. REMINGTON RD. Schaumburg, IL 60173 |
| Product Code | FYC |
| 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 | 1987-12-02 |