MULTIPLE BRAND MALE LATEX CONDOM
FDA 510(k) clearance K070937 · decided 2007-09-21
Clearance details
- K-number
- K070937
- Device name
- MULTIPLE BRAND MALE LATEX CONDOM
- Applicant
- Nulatex Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-04
- Decision date
- 2007-09-21
- Days to decision
- 170 days
- Clearance type
- Abbreviated
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Kluang, Johor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.