FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAC LEE VAGINAL IRRIGATOR
K Number: K841710
·
Decision Jun 19, 1984
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
11
Applicant Total
14
Review Days
56
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Basic Information
- Device Name
- MAC LEE VAGINAL IRRIGATOR
- K Number
- K841710
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Mac Lee Medical Products
- Date Received
- April 24, 1984
- Decision Date
- June 19, 1984
- Product Code
- HED
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HED | Douche Apparatus, Vaginal, Therapeutic | FDA class 1 | Obstetrics/Gynecology |
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P.A. MEDICAL VAGINAL IRRIGATION SET #1130
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Other Clearances by Mac Lee Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K872953 | DISPOSABLE I.V. ADMINISTRATION SET | Jan 6, 1988 | Substantially Equivalent |
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | Nov 17, 1987 | Substantially Equivalent |
| K870995 | SCALP VEIN SET | Jul 31, 1987 | Substantially Equivalent |
| K864778 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864779 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864777 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864781 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC | Dec 29, 1986 | Substantially Equivalent |
| K864782 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC | Dec 23, 1986 | Substantially Equivalent |
| K864783 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC | Dec 23, 1986 | Substantially Equivalent |
| K864780 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC | Dec 23, 1986 | Substantially Equivalent |