LASER BRONCHOSCOPE SYSTEM
FDA 510(k) clearance K861921 · decided 1986-06-02
Clearance details
- K-number
- K861921
- Device name
- LASER BRONCHOSCOPE SYSTEM
- Applicant
- Pilling Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-19
- Decision date
- 1986-06-02
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LLO
- Device class
- 2
- Regulation number
- 874.4500
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Fort Washington, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.