510(k) K952678
K952678 is an FDA 510(k) premarket notification submitted by Avail-Southwest Division for the device "STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT". The FDA issued a decision of Substantially Equivalent on July 10, 1995. The device falls under product code KDG (Chisel (Osteotome)), a Class I device regulated under 21 CFR 878.4820. Avail-Southwest Division has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1995
- Date Received
- June 12, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chisel (Osteotome)
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type