LARYNGOSCOPE BLADES
FDA 510(k) clearance K883414 · decided 1988-08-19
Clearance details
- K-number
- K883414
- Device name
- LARYNGOSCOPE BLADES
- Applicant
- Truphatek, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-15
- Decision date
- 1988-08-19
- Days to decision
- 4 days
- Clearance type
- Traditional
- Product code
- CCW
- Device class
- 1
- Regulation number
- 868.5540
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Netanya, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic la recall (Z-1225-06) | Teleflex Medical | 2006-07-13 |