FLEXIBLADE
FDA 510(k) clearance K984101 · decided 1999-09-03
Clearance details
- K-number
- K984101
- Device name
- FLEXIBLADE
- Applicant
- Arco Medic , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-17
- Decision date
- 1999-09-03
- Days to decision
- 290 days
- Clearance type
- Traditional
- Product code
- CCW
- Device class
- 1
- Regulation number
- 868.5540
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ra'Ananna 43373, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.