LUMINOUS 150 FIBEROPTIC ILLUMINATOR
FDA 510(k) clearance K933593 · decided 1993-10-28
Clearance details
- K-number
- K933593
- Device name
- LUMINOUS 150 FIBEROPTIC ILLUMINATOR
- Applicant
- Progressive Dynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-26
- Decision date
- 1993-10-28
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- HBI
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marshall, MI, US
- Third-party review
- No
- Expedited review
- No
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| ENDOSCOPIC FIBEROPTIC CABLE (K021931) | Gulf Medical Fiberoptics | 2002-09-06 |
| ENDOSCOPIC FIBEROPTIC CABLE (K991208) | Isolux America | 1999-06-23 |
| LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (K983277) | Cuda Products Co. | 1998-12-16 |
| S1500 XENON LIGHT SOURCE (K922837) | Endomedix | 1992-11-03 |
| NEXTEC FIBEROPTIC CABLES (K922462) | Nextec Corp. | 1992-09-21 |
| LUMINOUS 250 FIBEROPTIC ILLUMINATOR (K921866) | Progressive Dynamics, Inc. | 1992-07-08 |
| NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL (K920167) | Nextec Corp. | 1992-03-23 |
Recalls involving this device
No recalls on record reference this clearance.