ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL
FDA 510(k) clearance K915731 · decided 1992-11-05
Clearance details
- K-number
- K915731
- Device name
- ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL
- Applicant
- Elmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-20
- Decision date
- 1992-11-05
- Days to decision
- 321 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Addison, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.