FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERSONAL WARMING LUBRICANT
K Number: K040085
·
Decision Apr 20, 2004
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
6
Review Days
95
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Basic Information
- Device Name
- PERSONAL WARMING LUBRICANT
- K Number
- K040085
- 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
- January 16, 2004
- Decision Date
- April 20, 2004
- Product Code
- HIS
- 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 |
|---|---|---|---|
| HIS | Condom | FDA class 2 | Obstetrics/Gynecology |
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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 |
| K041129 | PERSONAL LUBRICATING GEL | Sep 24, 2004 | Substantially Equivalent |
| K973780 | PERSONAL LUBRICATING LIQUID | Nov 26, 1997 | Substantially Equivalent |
| K973557 | LUBRIGLIDE | Oct 10, 1997 | Substantially Equivalent |