The following data is part of a premarket notification filed by Milex Products, Inc. with the FDA for Milex Bartholin Gland Catheter.
| Device ID | K861385 |
| 510k Number | K861385 |
| Device Name: | MILEX BARTHOLIN GLAND CATHETER |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Contact | Robert Shaw |
| Correspondent | Robert Shaw MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-14 |
| Decision Date | 1986-06-16 |