The following data is part of a premarket notification filed by Promedica, Inc. with the FDA for The Ultra System Sp.
| Device ID | K032813 |
| 510k Number | K032813 |
| Device Name: | THE ULTRA SYSTEM SP |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | PROMEDICA, INC. 114 DOUGLAS RD EAST Oldsmar, FL 34677 |
| Contact | Richard Bloom |
| Correspondent | Richard Bloom PROMEDICA, INC. 114 DOUGLAS RD EAST Oldsmar, FL 34677 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-09 |
| Decision Date | 2004-02-13 |