TUNGSTEN SYRINGE SHIELD
FDA 510(k) clearance K811688 · decided 1981-07-02
Clearance details
- K-number
- K811688
- Device name
- TUNGSTEN SYRINGE SHIELD
- Applicant
- Medi-Physics Inc. Dba Nycomed Amersham Imaging
- Decision
- Substantially Equivalent
- Date received
- 1981-06-15
- Decision date
- 1981-07-02
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- IWR
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medi-Physics Inc. Dba Nycomed Amersham Imaging
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| LEAD GLASS SHIELDS (K872656) | Viox Corp. | 1987-07-16 |
| DUFFY BOLUS INJECTOR (K863936) | Viox Corp. | 1987-01-06 |
Recalls involving this device
No recalls on record reference this clearance.