FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
K Number: K992438
·
Decision Aug 2, 1999
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
21
Applicant Total
8
Review Days
11
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Basic Information
- Device Name
- INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
- K Number
- K992438
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5310
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Indus Medicare , Ltd.
- Date Received
- July 22, 1999
- Decision Date
- August 2, 1999
- Product Code
- LTZ
- 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 |
|---|---|---|---|
| LTZ | Condom With Nonoxynol-9 | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LTZ), ordered by most recent decision date.
CAUTION CONDOMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DOUBLE SPRINGERS NONOXNOL 9 CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Indus Medicare , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K022614 | INVIGRA | Apr 8, 2003 | Substantially Equivalent |
| K020223 | INVIGRA | Mar 4, 2002 | Substantially Equivalent |
| K000038 | INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED | Mar 21, 2000 | Substantially Equivalent |
| K000039 | INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED | Mar 21, 2000 | Substantially Equivalent |
| K000040 | INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED | Mar 21, 2000 | Substantially Equivalent |
| K993693 | INVIGRA | Dec 29, 1999 | Substantially Equivalent |
| K991374 | INVIGRA | Jun 15, 1999 | Substantially Equivalent |