FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-Y PERSONAL LUBRICANT
K Number: K955648
·
Decision Jun 21, 1996
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
9
Review Days
192
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Basic Information
- Device Name
- K-Y PERSONAL LUBRICANT
- K Number
- K955648
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Pharmaceutical Corp.
- Date Received
- December 12, 1995
- Decision Date
- June 21, 1996
- 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 Ortho Pharmaceutical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934516 | ADVANCE PREGNANCY TEST MODIFICATION | Feb 24, 1994 | Substantially Equivalent |
| K914990 | ADVANCE(R) PREGNANCY TEST | Dec 23, 1991 | Substantially Equivalent |
| K893488 | PULSATILE PUMP FOR GONADORELIN ACETATE | Oct 31, 1989 | Substantially Equivalent |
| K881151 | MICROSCRAPE | Apr 6, 1988 | Substantially Equivalent |
| K810581 | FACT* HOME PREGNANCY TEST | Mar 17, 1981 | Substantially Equivalent |
| K800754 | NICKERSON'S MED. SELECTIVE CULTURE MEDIU | Apr 29, 1980 | Substantially Equivalent |
| K792634 | CONCEPTROL/THIN PROPHYLACTICS | Jan 16, 1980 | Substantially Equivalent |
| K790087 | LUBRICANT, OTRHO PERSONAL | Feb 1, 1979 | Substantially Equivalent |