SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT
FDA 510(k) clearance K760448 · decided 1976-08-27
Clearance details
- K-number
- K760448
- Device name
- SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1976-08-16
- Decision date
- 1976-08-27
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- DXL
- Device class
- 2
- Regulation number
- 870.1660
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, 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 |
|---|---|---|
| TUBE, HEAVY GLASS WALL INJECTION (K760500) | Unimetrics Corp. | 1976-09-03 |
| TRAY, ICED INJECTABLE (26420) (K760066) | Instrumentation Laboratory CO | 1976-07-21 |
Recalls involving this device
No recalls on record reference this clearance.