LARGE/EXTRA LAGRE CONDOM
FDA 510(k) clearance K113061 · decided 2011-12-07
Clearance details
- K-number
- K113061
- Device name
- LARGE/EXTRA LAGRE CONDOM
- Applicant
- Karex Industries Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-14
- Decision date
- 2011-12-07
- Days to decision
- 54 days
- Clearance type
- Special
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Johor Darul Takzim, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.