The following data is part of a premarket notification filed by Mac Lee Medical Products with the FDA for Mac Lee Vaginal Irrigator.
| Device ID | K841710 |
| 510k Number | K841710 |
| Device Name: | MAC LEE VAGINAL IRRIGATOR |
| Classification | Douche Apparatus, Vaginal, Therapeutic |
| Applicant | MAC LEE MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HED |
| CFR Regulation Number | 884.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-24 |
| Decision Date | 1984-06-19 |