The following data is part of a premarket notification filed by Hakki Medical Technologies, Inc. with the FDA for Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French.
| Device ID | K101900 |
| 510k Number | K101900 |
| Device Name: | HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH |
| Classification | Catheter, Urethral |
| Applicant | HAKKI MEDICAL TECHNOLOGIES, INC. 3851 62ND AVE. NORTH SUITE A Pinellas Park, FL 33781 |
| Contact | Andrew Endahl |
| Correspondent | Andrew Endahl HAKKI MEDICAL TECHNOLOGIES, INC. 3851 62ND AVE. NORTH SUITE A Pinellas Park, FL 33781 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-07 |
| Decision Date | 2011-02-07 |
| Summary: | summary |