510(k) K963305
K963305 is an FDA 510(k) premarket notification submitted by Alexander Mfg. Co. for the device "ALEXANDER BOX, BATTERY, RECHARGEABLE". The FDA issued a decision of Substantially Equivalent on April 17, 1997. The device falls under product code BWA (Unit, Electrosurgical And Coagulation, With Accessories), a Class II device regulated under 21 CFR 878.4400. Alexander Mfg. Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 1997
- Date Received
- August 22, 1996
- 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