FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
K Number: K974324
·
Decision Feb 9, 1998
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
21
Applicant Total
4
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
- K Number
- K974324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5310
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Reddy Medtech Health Products , Ltd.
- Date Received
- November 18, 1997
- Decision Date
- February 9, 1998
- 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