510(k) K983045
K983045 is an FDA 510(k) premarket notification submitted by Owen Mumford USA, Inc. for the device "AMIELLE". The FDA issued a decision of Substantially Equivalent on November 25, 1998. The device falls under product code KXP (Stent, Vaginal), a Class II device regulated under 21 CFR 884.3900. Owen Mumford USA, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1998
- Date Received
- September 1, 1998
- 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