ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
FDA 510(k) clearance K844765 · decided 1985-04-08
Clearance details
- K-number
- K844765
- Device name
- ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
- Applicant
- Laser Spectrum, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-07
- Decision date
- 1985-04-08
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- EWQ
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FELDMAN MINI-SAW, #300000 (K800669) | KARL STORZ Endoscopy-America, Inc. | 1980-04-21 |
Recalls involving this device
No recalls on record reference this clearance.