510(k) K932345
K932345 is an FDA 510(k) premarket notification submitted by Conmedcorp for the device "TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE". The FDA issued a decision of Substantially Equivalent on April 12, 1994. The device falls under product code DWG (Electrosurgical Device), a Class II device regulated under 21 CFR 878.4400. Conmedcorp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1994
- Date Received
- May 14, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrosurgical Device
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type