510(k) K970577
K970577 is an FDA 510(k) premarket notification submitted by Glyde USA, Inc. for the device "GLYDE DAM LOLLYES". The FDA issued a decision of Substantially Equivalent on January 8, 1998. 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
- January 8, 1998
- Date Received
- February 14, 1997
- 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