FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONE PERSONAL LUBRICANT (SILICONE)
K Number: K110690
·
Decision Mar 28, 2012
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
230
Applicant Total
2
Review Days
383
Basic Information
- Device Name
- ONE PERSONAL LUBRICANT (SILICONE)
- K Number
- K110690
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ONE
- Date Received
- March 11, 2011
- Decision Date
- March 28, 2012
- 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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Other Clearances by ONE
| K Number | Device Name | ||
|---|---|---|---|
| K110691 | ONE PERSONAL LUBRICANT (WATER BASED) | Feb 1, 2012 | Substantially Equivalent |