EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS
FDA 510(k) clearance K844774 · decided 1985-04-22
Clearance details
- K-number
- K844774
- Device name
- EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS
- Applicant
- Mecron Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-10
- Decision date
- 1985-04-22
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- FCR
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Port Washington, NY, 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 |
|---|---|---|
| A O FIBER OPTIC ILLUMINATOR, 1185B (K821754) | Warner-Lambert Co. | 1982-06-24 |
| A O FIBER OPTIC ILLUMINATION, 1185A (K821753) | Warner-Lambert Co. | 1982-06-24 |
Recalls involving this device
No recalls on record reference this clearance.