CONQUEROR, RUMBA AND TEMPTATION
FDA 510(k) clearance K946207 · decided 1996-01-24
Clearance details
- K-number
- K946207
- Device name
- CONQUEROR, RUMBA AND TEMPTATION
- Applicant
- Frontline Latex Products Pvt. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-21
- Decision date
- 1996-01-24
- Days to decision
- 399 days
- Clearance type
- Traditional
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.