SUREONE INSULIN SYRINGE
FDA 510(k) clearance K002921 · decided 2000-10-18
Clearance details
- K-number
- K002921
- Device name
- SUREONE INSULIN SYRINGE
- Applicant
- Hosuk Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-19
- Decision date
- 2000-10-18
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Umsung-Gun, Chungcheong, KR
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes recall (Z-0003-04) | Liberty Medical Supplies | 2003-10-15 |
| Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syr recall (Z-0004-04) | Liberty Medical Supplies | 2003-10-15 |
| Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin s recall (Z-0005-04) | Liberty Medical Supplies | 2003-10-15 |