510(k) K974121
K974121 is an FDA 510(k) premarket notification submitted by Sensicon Corp. for the device "LUBRICATED BAGGY TACTYLON CONDOM". The FDA issued a decision of Substantially Equivalent on January 29, 1998. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Sensicon Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1998
- Date Received
- October 31, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom, Synthetic
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type