The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Sterile Custom Surgical Kits.
| Device ID | K914244 |
| 510k Number | K914244 |
| Device Name: | STERILE CUSTOM SURGICAL KITS |
| Classification | Kit, Surgical Instrument, Disposable |
| 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 | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-23 |
| Decision Date | 1992-02-24 |