FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
HyaloGYN Vaginal Hydrating Gel
K Number: K150883
·
Decision Sep 1, 2015
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
230
Applicant Total
2
Review Days
152
Basic Information
- Device Name
- HyaloGYN Vaginal Hydrating Gel
- K Number
- K150883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FIDIA FARMACEUTICI SPA
- Date Received
- April 2, 2015
- Decision Date
- September 1, 2015
- 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 FIDIA FARMACEUTICI SPA
| K Number | Device Name | ||
|---|---|---|---|
| K094039 | HYALO GYN | May 7, 2010 | Substantially Equivalent |