TROJAN (TM-TBD) CONDOM
FDA 510(k) clearance K912901 · decided 1992-02-03
Clearance details
- K-number
- K912901
- Device name
- TROJAN (TM-TBD) CONDOM
- Applicant
- Carter Products
- Decision
- Substantially Equivalent
- Date received
- 1991-07-02
- Decision date
- 1992-02-03
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- 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.