The following data is part of a premarket notification filed by Oasis Medikal Urunler Kimya Sanayi Ve Tic A.s. with the FDA for Hi-slip And Hi-slip Plus Single Use Hydrophilic Urinary Catheters And Kit.
| Device ID | K062444 |
| 510k Number | K062444 |
| Device Name: | HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT |
| Classification | Catheter, Straight |
| Applicant | OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S. 208 BARRINGTON OVERLOOK Durham, NC 27703 |
| Contact | Charles H Kyper |
| Correspondent | Charles H Kyper OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S. 208 BARRINGTON OVERLOOK Durham, NC 27703 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-21 |
| Decision Date | 2007-02-22 |
| Summary: | summary |