The following data is part of a premarket notification filed by Medical Device Systems, Inc. with the FDA for The Ultra.
| Device ID | K935755 |
| 510k Number | K935755 |
| Device Name: | THE ULTRA |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MEDICAL DEVICE SYSTEMS, INC. 212 EAST PARK ST. Auburndale, FL 33823 |
| Contact | John S Bodolay |
| Correspondent | John S Bodolay MEDICAL DEVICE SYSTEMS, INC. 212 EAST PARK ST. Auburndale, FL 33823 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-26 |
| Decision Date | 1995-05-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THE ULTRA 73291784 not registered Dead/Abandoned |
HOLLAND, DENNIS P. 0000-00-00 |