510(k) K974479
K974479 is an FDA 510(k) premarket notification submitted by Silimed, LLC for the device "SILIMED VAGINAL STENT". The FDA issued a decision of Substantially Equivalent on August 5, 1998. The device falls under product code KXP (Stent, Vaginal), a Class II device regulated under 21 CFR 884.3900. Silimed, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1998
- Date Received
- November 26, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3900
- Review Panel
- OB
- Submission Type