FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
DOUBLE SPRINGERS NONOXNOL 9 CONDOM
K Number: K012969
·
Decision Jun 12, 2002
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
21
Applicant Total
5
Review Days
281
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Basic Information
- Device Name
- DOUBLE SPRINGERS NONOXNOL 9 CONDOM
- K Number
- K012969
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5310
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtech Products , Ltd.
- Date Received
- September 4, 2001
- Decision Date
- June 12, 2002
- 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
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