The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Y-type Tur/bladder Irrigation Set.
| Device ID | K970946 |
| 510k Number | K970946 |
| Device Name: | MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET |
| Classification | System, Irrigation, Urological |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Contact | Christine Galea |
| Correspondent | Christine Galea MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-14 |
| Decision Date | 1997-06-10 |
| Summary: | summary |