510(k) K884503
K884503 is an FDA 510(k) premarket notification submitted by Herbert Stanley Co. for the device "ULTRASONIC TRANSMISSION GEL". The FDA issued a decision of Substantially Equivalent on February 13, 1989. The device falls under product code JOT (Electrode, Gel, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Herbert Stanley Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1989
- Date Received
- October 25, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Gel, Electrosurgical
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type