EFF-EFFNER BULBS
FDA 510(k) clearance K844773 · decided 1985-01-08
Clearance details
- K-number
- K844773
- Device name
- EFF-EFFNER BULBS
- Applicant
- Mecron Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-10
- Decision date
- 1985-01-08
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FFS
- 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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| FIBER OPTIC ENDOILLUMINATION PROBE (K982462) | Microvision, Inc. | 1998-09-14 |
| FIBER OPTIC ENDOILLUMINATION PROBE (K980636) | Dutch Ophthalmic USA, Inc. | 1998-05-20 |
| VISTA ILLUMINATION SYSTEM (K970217) | Vista Medical Technologies, Inc. | 1997-04-02 |
Recalls involving this device
No recalls on record reference this clearance.