VYGON SPINAL ANESTHESIA TRAY CODE NO. 190
FDA 510(k) clearance K851474 · decided 1985-05-07
Clearance details
- K-number
- K851474
- Device name
- VYGON SPINAL ANESTHESIA TRAY CODE NO. 190
- Applicant
- Vygon Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-15
- Decision date
- 1985-05-07
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- LAZ
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- East Rutherford, NJ, 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 |
|---|---|---|
| Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) (K211667) | Changzhou Universal Medical Equipment Co., Ltd. | 2021-09-23 |
| ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL (K823127) | Syva Co. | 1982-11-29 |
| EMIT-AND METHOTREXATE CONTROL (K811461) | Syva Co. | 1981-06-09 |
Recalls involving this device
No recalls on record reference this clearance.