MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
FDA 510(k) clearance K852544 · decided 1985-07-23
Clearance details
- K-number
- K852544
- Device name
- MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-14
- Decision date
- 1985-07-23
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3c recall (Z-0051-2007) | Kendall a Division of Tyco Healthcare Group LP | 2006-10-21 |