KIMONO (CONDOMS)
FDA 510(k) clearance K872799 · decided 1987-12-08
Clearance details
- K-number
- K872799
- Device name
- KIMONO (CONDOMS)
- Applicant
- Mayer Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-07-15
- Decision date
- 1987-12-08
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Oakland, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.