510(k) K091769
K091769 is an FDA 510(k) premarket notification submitted by Line One Laboratories, Inc. for the device "TRUST DAM". The FDA issued a decision of Substantially Equivalent on February 5, 2010. The device falls under product code MSC (Barrier, Std, Oral Sex), a Class II device regulated under 21 CFR 884.5300. Line One Laboratories, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2010
- Date Received
- June 16, 2009
- Clearance Type
- Abbreviated
- 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