510(k) K954912
K954912 is an FDA 510(k) premarket notification submitted by Trebay Medical Corp. for the device "TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on December 6, 1995. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Trebay Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 1995
- Date Received
- October 23, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bur, Ear, Nose And Throat
- Device Class
- Class I
- Regulation Number
- 874.4140
- Review Panel
- EN
- Submission Type