PENCIL, ELECTROSURGICAL
FDA 510(k) clearance K760168 · decided 1976-08-09
Clearance details
- K-number
- K760168
- Device name
- PENCIL, ELECTROSURGICAL
- Applicant
- Dytek Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-07-06
- Decision date
- 1976-08-09
- Days to decision
- 34 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.