PERSONAL LUBRICATING LIQUID
FDA 510(k) clearance K973780 · decided 1997-11-26
Clearance details
- K-number
- K973780
- Device name
- PERSONAL LUBRICATING LIQUID
- Applicant
- Qualis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-03
- Decision date
- 1997-11-26
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Des Moines, IA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.