510(k) K041985
K041985 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "XPS CURVED BUR". The FDA issued a decision of Substantially Equivalent on August 12, 2004. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2004
- Date Received
- July 23, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Bur, Ear, Nose And Throat
- Device Class
- Class I
- Regulation Number
- 874.4140
- Review Panel
- EN
- Submission Type