FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-Y BRAND WARMING LIQUID
K Number: K070545
·
Decision Mar 23, 2007
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
45
Review Days
25
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Basic Information
- Device Name
- K-Y BRAND WARMING LIQUID
- K Number
- K070545
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Personal Products Co.
- Date Received
- February 26, 2007
- Decision Date
- March 23, 2007
- 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 Personal Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K062796 | K-Y BRAND INTRIGUE | Dec 8, 2006 | Substantially Equivalent |
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Apr 30, 2001 | Substantially Equivalent |
| K990536 | O.B. TAMPON | Aug 31, 1999 | Substantially Equivalent |
| K991118 | O.B. APPLICATOR TAMPONS, O.B. TAMPONS | Jun 29, 1999 | Substantially Equivalent |
| K974629 | O.B. APPLICATOR AND NON-APPLICATOR TAMPONS | Feb 10, 1998 | Substantially Equivalent |
| K971589 | REACH ANTIBACTERIAL TOOTHBRUSH | Jul 24, 1997 | Substantially Equivalent |
| K970954 | O.B. APPLICATOR TAMPONS | Jun 10, 1997 | Substantially Equivalent |
| K961119 | CAREFREE PANTYLINERS | Apr 17, 1996 | Substantially Equivalent |
| K953638 | O.B. APPLICATOR TAMPONS | Oct 20, 1995 | Substantially Equivalent |
| K941863 | O.B. TAMPON | Jun 27, 1994 | Substantially Equivalent |