DUREX PLAY TINGLING LUBRICANT
FDA 510(k) clearance K042958 · decided 2005-04-08
Clearance details
- K-number
- K042958
- Device name
- DUREX PLAY TINGLING LUBRICANT
- Applicant
- Ssl Americas, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-27
- Decision date
- 2005-04-08
- Days to decision
- 163 days
- Clearance type
- Abbreviated
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.