KINETIC MODEL 132
FDA 510(k) clearance K891758 · decided 1989-04-19
Clearance details
- K-number
- K891758
- Device name
- KINETIC MODEL 132
- Applicant
- Kinetic Biomedical Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-23
- Decision date
- 1989-04-19
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- FSS
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Erie, PA, US
- Third-party review
- No
- Expedited review
- No
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| CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (K981962) | Cuda Products Co. | 1998-08-18 |
| VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (K981821) | Angiolaz, Inc. | 1998-07-29 |
| CERMAX300 LIGHTSOURCE (K981469) | Cuda Products Co. | 1998-07-09 |
| XENON 300MX (K980044) | Perkinelmer Optoelectronics | 1998-04-03 |
| HANAULUX BLUE 80 HOSPITAL (K970886) | Heraeus Med GmbH | 1997-04-16 |
| Q-5000 (K961971) | Stryker Endoscopy | 1996-06-28 |
| LIGHTSOURCE OR ILLUMINATOR (K961074) | Cuda Products Co. | 1996-04-30 |
| TRI*STAR (K930711) | Light Technology Systems | 1993-07-30 |
| AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT (K910942) | Mdt Biologic Co. | 1991-06-11 |
Recalls involving this device
No recalls on record reference this clearance.