510(k) K990067
K990067 is an FDA 510(k) premarket notification submitted by Louise C. Myers for the device "SHEER GLYDE DAMS". The FDA issued a decision of Substantially Equivalent on February 19, 1999. The device falls under product code MSC (Barrier, Std, Oral Sex), a Class II device regulated under 21 CFR 884.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1999
- Date Received
- January 8, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Barrier, Std, Oral Sex
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type