510(k) K893499
K893499 is an FDA 510(k) premarket notification submitted by Cmsi for the device "CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS". The FDA issued a decision of Substantially Equivalent on November 16, 1989. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Cmsi has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1989
- Date Received
- May 4, 1989
- 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