FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUBRICANT, OTRHO PERSONAL
K Number: K790087
·
Decision Feb 1, 1979
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
9
Review Days
15
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Basic Information
- Device Name
- LUBRICANT, OTRHO PERSONAL
- K Number
- K790087
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ortho Pharmaceutical Corp.
- Date Received
- January 17, 1979
- Decision Date
- February 1, 1979
- Product Code
- KMJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KMJ | Lubricant, Patient | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by Ortho Pharmaceutical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955648 | K-Y PERSONAL LUBRICANT | Jun 21, 1996 | Substantially Equivalent |
| 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 |