IMC PISTON SYRINGES
FDA 510(k) clearance K102969 · decided 2010-12-20
Clearance details
- K-number
- K102969
- Device name
- IMC PISTON SYRINGES
- Applicant
- International Medsurg Connection
- Decision
- Substantially Equivalent
- Date received
- 2010-10-06
- Decision date
- 2010-12-20
- Days to decision
- 75 days
- Clearance type
- Special
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Schaumburg, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care T recall (Z-0938-2023) | Stradis Healthcare | 2023-01-11 |
| HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Techno recall (Z-0939-2023) | Stradis Healthcare | 2023-01-11 |