FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PJUR EROS WATER FORMULATION
K Number: K010199
·
Decision Apr 5, 2001
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
1
Review Days
73
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Basic Information
- Device Name
- PJUR EROS WATER FORMULATION
- K Number
- K010199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- L.C.C. Pjur Group Germany
- Date Received
- January 22, 2001
- Decision Date
- April 5, 2001
- Product Code
- NUC
- 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 |
|---|---|---|---|
| NUC | Lubricant, Personal | FDA class 2 | Obstetrics/Gynecology |
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