FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
K Number: K133336
·
Decision Jul 24, 2014
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
230
Applicant Total
1
Review Days
268
Basic Information
- Device Name
- PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
- K Number
- K133336
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PJUR GROUP,LUXEMBOURG S.A.
- Date Received
- October 29, 2013
- Decision Date
- July 24, 2014
- 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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