TACTYLON CONDOM
FDA 510(k) clearance K971590 · decided 1997-10-07
Clearance details
- K-number
- K971590
- Device name
- TACTYLON CONDOM
- Applicant
- Sensicon Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-01
- Decision date
- 1997-10-07
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- MOL
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.