LEAD GLASS SHIELDS
FDA 510(k) clearance K872656 · decided 1987-07-16
Clearance details
- K-number
- K872656
- Device name
- LEAD GLASS SHIELDS
- Applicant
- Viox Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-07
- Decision date
- 1987-07-16
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- IWR
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seattle, WA, 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 |
|---|---|---|
| ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD (K934549) | Victoreen, Inc. | 1994-02-19 |
| DUFFY BOLUS INJECTOR (K863936) | Viox Corp. | 1987-01-06 |
| TUNGSTEN SYRINGE SHIELD (K811688) | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-07-02 |
Recalls involving this device
No recalls on record reference this clearance.