ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
FDA 510(k) clearance K003403 · decided 2001-05-07
Clearance details
- K-number
- K003403
- Device name
- ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
- Applicant
- Highland / Marietta, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-01
- Decision date
- 2001-05-07
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- JOS
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.