K841710 is an FDA 510(k) clearance for the MAC LEE VAGINAL IRRIGATOR. This device is classified as a Douche Apparatus, Vaginal, Therapeutic (Class I - General Controls, product code HED).
Submitted by Mac Lee Medical Products (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984, 56 days after receiving the submission on April 24, 1984.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5900.
| 510(k) Number | K841710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 1984 |
| Decision Date | June 19, 1984 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HED — Douche Apparatus, Vaginal, Therapeutic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.5900 |