ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),
FDA 510(k) clearance K001161 · decided 2000-06-07
Clearance details
- K-number
- K001161
- Device name
- ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),
- Applicant
- Conmedcorp
- Decision
- Substantially Equivalent
- Date received
- 2000-04-10
- Decision date
- 2000-06-07
- Days to decision
- 58 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
- Centennial, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.