510(k) K874719
K874719 is an FDA 510(k) premarket notification submitted by Alternative Design Systems, Inc. for the device "STRATUM ESU". The FDA issued a decision of Substantially Equivalent on February 16, 1988. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Alternative Design Systems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1988
- Date Received
- November 17, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrosurgical
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type