The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Absorbent Fiber.
| Device ID | K914431 |
| 510k Number | K914431 |
| Device Name: | ABSORBENT FIBER |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | ULTI-MED INTL., INC. 1688 GLEN ELLYN RD. Glendale Heights, IL 60139 |
| Contact | David Insco |
| Correspondent | David Insco ULTI-MED INTL., INC. 1688 GLEN ELLYN RD. Glendale Heights, IL 60139 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-04 |
| Decision Date | 1991-12-04 |