ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
FDA 510(k) clearance K961097 · decided 1996-06-03
Clearance details
- K-number
- K961097
- Device name
- ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
- Applicant
- Debusk Knitting Mills, Div. Deroyal Industries
- Decision
- Substantially Equivalent
- Date received
- 1996-03-19
- Decision date
- 1996-06-03
- Days to decision
- 76 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
- Powell, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.