MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
FDA 510(k) clearance K904273 · decided 1990-10-31
Clearance details
- K-number
- K904273
- Device name
- MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
- Applicant
- Carter Products
- Decision
- Substantially Equivalent
- Date received
- 1990-09-17
- Decision date
- 1990-10-31
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- LTZ
- Device class
- 2
- Regulation number
- 884.5310
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cranbury, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.