The following data is part of a premarket notification filed by Medical Inventors Corp., Inc. with the FDA for Microcycler.
| Device ID | K915166 |
| 510k Number | K915166 |
| Device Name: | MICROCYCLER |
| Classification | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Applicant | MEDICAL INVENTORS CORP., INC. 7575 DR. PHILLIPS BLVD., SUITE #310 Orlando, FL 32819 |
| Contact | Roland C Zagnoli |
| Correspondent | Roland C Zagnoli MEDICAL INVENTORS CORP., INC. 7575 DR. PHILLIPS BLVD., SUITE #310 Orlando, FL 32819 |
| Product Code | FCN |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1994-09-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MICROCYCLER 87453874 5618338 Live/Registered |
Microbiologique, Inc. 2017-05-17 |
![]() MICROCYCLER 73816599 1589832 Dead/Cancelled |
MEDICAL INVENTORS CORPORATION 1989-08-02 |