The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Surgical Instrument Kit, Disposable.
| Device ID | K923175 |
| 510k Number | K923175 |
| Device Name: | SURGICAL INSTRUMENT KIT, DISPOSABLE |
| Classification | Patient Examination Glove |
| 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 | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-12 |
| Decision Date | 1993-06-17 |