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 |