MEDLINE SYRINGES, MULTIPLE
FDA 510(k) clearance K061275 · decided 2006-07-19
Clearance details
- K-number
- K061275
- Device name
- MEDLINE SYRINGES, MULTIPLE
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-08
- Decision date
- 2006-07-19
- Days to decision
- 72 days
- Clearance type
- Abbreviated
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mundelein, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010 recall (Z-1937-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-05-31 |
| MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020 recall (Z-1938-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-05-31 |