510(k) K003403
K003403 is an FDA 510(k) premarket notification submitted by Highland / Marietta, Inc. for the device "ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999". The FDA issued a decision of Substantially Equivalent on May 7, 2001. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Highland / Marietta, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2001
- Date Received
- November 1, 2000
- 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