FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUNE AU CURETTES
K Number: K850068
·
Decision Apr 8, 1985
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
10
Applicant Total
5
Review Days
90
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Basic Information
- Device Name
- LUNE AU CURETTES
- K Number
- K850068
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Luneau Laboratories
- Date Received
- January 8, 1985
- Decision Date
- April 8, 1985
- Product Code
- HCY
- 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 |
|---|---|---|---|
| HCY | Curette, Uterine | FDA class 1 | Obstetrics/Gynecology |
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