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 |