AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
FDA 510(k) clearance K130345 · decided 2013-08-01
Clearance details
- K-number
- K130345
- Device name
- AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
- Applicant
- Mayer Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-11
- Decision date
- 2013-08-01
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Berkely, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.