SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
FDA 510(k) clearance K021197 · decided 2002-04-26
Clearance details
- K-number
- K021197
- Device name
- SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
- Applicant
- Hosuk Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-16
- Decision date
- 2002-04-26
- Days to decision
- 10 days
- Clearance type
- Special
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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