MAC LEE VAGINAL IRRIGATOR
FDA 510(k) clearance K841710 · decided 1984-06-19
Clearance details
- K-number
- K841710
- Device name
- MAC LEE VAGINAL IRRIGATOR
- Applicant
- Mac Lee Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1984-04-24
- Decision date
- 1984-06-19
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- HED
- Device class
- 1
- Regulation number
- 884.5900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WATER WORKS DOUCHING DEVICE (K080200) | Abbott Research Group, Inc. | 2008-07-10 |
| WORRY-REMOVER IRRIGATOR (K030056) | Corisen Group, Ltd. | 2003-04-22 |
| LA JOIE (K000736) | Goomi Ehwa, Inc. | 2000-08-08 |
| PERI-BOTTLE (K902830) | Orion Life Systems, Inc. | 1990-08-06 |
| GENT-L-KARE VAGINAL IRRIGATION SET (K881216) | Geneva Laboratories, Inc. | 1988-06-07 |
| P.A. MEDICAL VAGINAL IRRIGATION SET #1130 (K854595) | Pa Medical Corp. | 1986-01-13 |
| FEMININE HYGIENE DEVICE (K831667) | Snow Willow Co. | 1983-09-12 |
| DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID (K800954) | The Healthcare Group Laboratories, Inc. | 1980-10-03 |
| DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN (K800956) | The Healthcare Group Laboratories, Inc. | 1980-10-03 |
| DOUCHE UNIT-1500 ML DISP. CONTAINER (K800957) | The Healthcare Group Laboratories, Inc. | 1980-07-14 |
| DOUCHE KIT, SOMETHING PERSONAL (K781207) | Chatten Drug & Chemical Co. | 1978-08-10 |
Recalls involving this device
No recalls on record reference this clearance.