NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
FDA 510(k) clearance K002393 · decided 2000-12-19
Clearance details
- K-number
- K002393
- Device name
- NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
- Applicant
- Innolatex Sdn. Bhd
- Decision
- Substantially Equivalent
- Date received
- 2000-08-07
- Decision date
- 2000-12-19
- Days to decision
- 134 days
- Clearance type
- Abbreviated
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shah Alam,Selangor Darul Ehsan, MY
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Innolatex Sdn. Bhd
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.