510(k) K841710
- Device
- MAC LEE VAGINAL IRRIGATOR
- Applicant
- MAC LEE MEDICAL PRODUCTS
- 510(k) number
- K841710
- Product code
- HED
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-06-19
- Date received
- 1984-04-24
- Regulation
- 884.5900
- Classification name
- Douche Apparatus, Vaginal, Therapeutic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3012896103
- 9680411
- 9680168
- 1423537
- 3016872092
- 3012030719
- 1000328618
- 3005669815
- 3042277215
- 3008338766
- 3009648765
- 3010683450
- 8010730
- 3023229437
- 3027605322
- 3005327291
- 2183416
- 3021593882
- 2029015
- 3005271071
- 1921846
- 1043646
- 3006542501
- 3013496867
- 3010409218
- 3026848699
- 3020998419
- 3011209790
- 3008412545
- 9710020
- 3026182452
- 3008572203
- 9613910
- 1037752
- 3017177487
- 2022474
- 3022833366
- 9612030
- 3005273623
- 3003965134
- 3015474594
- 3014266447
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HED #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080200 | WATER WORKS DOUCHING DEVICE | Abbott Research Group, Inc. | 2008-07-10 |
| K030056 | WORRY-REMOVER IRRIGATOR | Corisen Group, Ltd. | 2003-04-22 |
| K000736 | LA JOIE | Goomi Ehwa, Inc. | 2000-08-08 |
| K902830 | PERI-BOTTLE | Orion Life Systems, Inc. | 1990-08-06 |
| K881216 | GENT-L-KARE VAGINAL IRRIGATION SET | Geneva Laboratories, Inc. | 1988-06-07 |
| K854595 | P.A. MEDICAL VAGINAL IRRIGATION SET #1130 | Pa Medical Corp. | 1986-01-13 |
| K831667 | FEMININE HYGIENE DEVICE | Snow Willow Co. | 1983-09-12 |
| K800954 | DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID | The Healthcare Group Laboratories, Inc. | 1980-10-03 |
| K800956 | DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN | The Healthcare Group Laboratories, Inc. | 1980-10-03 |
| K800957 | DOUCHE UNIT-1500 ML DISP. CONTAINER | The Healthcare Group Laboratories, Inc. | 1980-07-14 |
| K781207 | DOUCHE KIT, SOMETHING PERSONAL | Chatten Drug & Chemical Co. | 1978-08-10 |
Legacy Summary#
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FDA Review#
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