FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERSONAL LUBRICATING GEL
K Number: K041129
·
Decision Sep 24, 2004
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
6
Review Days
147
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Basic Information
- Device Name
- PERSONAL LUBRICATING GEL
- K Number
- K041129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qualis, Inc.
- Date Received
- April 30, 2004
- Decision Date
- September 24, 2004
- 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 |
Similar 510(k) Clearances
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Other Clearances by Qualis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050212 | PERSONAL WARMING JELLY | Mar 17, 2005 | Substantially Equivalent |
| K050211 | PERSONAL WARMING GEL | Mar 17, 2005 | Substantially Equivalent |
| K040085 | PERSONAL WARMING LUBRICANT | Apr 20, 2004 | Substantially Equivalent |
| K973780 | PERSONAL LUBRICATING LIQUID | Nov 26, 1997 | Substantially Equivalent |
| K973557 | LUBRIGLIDE | Oct 10, 1997 | Substantially Equivalent |