510(k) K873809
K873809 is an FDA 510(k) premarket notification submitted by Zimmer Aspen Labs for the device "EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001". The FDA issued a decision of Substantially Equivalent on November 20, 1987. The device falls under product code BWA (Unit, Electrosurgical And Coagulation, With Accessories), a Class II device regulated under 21 CFR 878.4400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1987
- Date Received
- September 18, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical And Coagulation, With Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type