FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Astroglide O Oil Personal Lubricant & Massage Oil
K Number: K171985
·
Decision Aug 30, 2017
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
230
Applicant Total
7
Review Days
58
Basic Information
- Device Name
- Astroglide O Oil Personal Lubricant & Massage Oil
- K Number
- K171985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BioFilm Inc.
- Date Received
- July 3, 2017
- Decision Date
- August 30, 2017
- 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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|---|---|---|---|
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