EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
FDA 510(k) clearance K972430 · decided 1997-09-10
Clearance details
- K-number
- K972430
- Device name
- EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
- Applicant
- Custom Services Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-27
- Decision date
- 1997-09-10
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- LTZ
- Device class
- 2
- Regulation number
- 884.5310
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Las Vegas, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.