510(k) K955636
K955636 is an FDA 510(k) premarket notification submitted by Sentry Medical Products, Inc. for the device "SENTRY DISPOSABLE DISPERSIVE ELECTRODE". The FDA issued a decision of Substantially Equivalent on March 27, 1996. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Sentry Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 1996
- Date Received
- December 11, 1995
- 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