510(k) K003375
- Device
- CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
- Applicant
- Tecnilatex S.A.
- 510(k) number
- K003375
- Product code
- LTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-01-28
- Date received
- 2000-10-30
- Regulation
- 884.5310
- Classification name
- Condom With Nonoxynol-9
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- JOSE M VAZQUEZ MARTIN
- Address
- Apdo. Correos, 156 C/Fraguas, 2 Alcorcon Madrid ES 28923 28923
FDA Registration Numbers#
- 3003592318
- 3013770781
- 3008808138
- 9613994
- 3003491851
- 3003759643
- 9613932
- 3021234378
- 2280705
- 8040641
- 1000136042
- 1122329
Source Documents#
510(k) summary PDF not indicated by FDA