MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
FDA 510(k) clearance K990669 · decided 1999-05-17
Clearance details
- K-number
- K990669
- Device name
- MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
- Applicant
- Dongkuk Techco Rubber Industries Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-02
- Decision date
- 1999-05-17
- Days to decision
- 76 days
- Clearance type
- Abbreviated
- Product code
- LTZ
- Device class
- 2
- Regulation number
- 884.5310
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Penang, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.