ULTICARE DISPOSABLE SYRINGES AND NEEDLES
FDA 510(k) clearance K062702 · decided 2006-11-29
Clearance details
- K-number
- K062702
- Device name
- ULTICARE DISPOSABLE SYRINGES AND NEEDLES
- Applicant
- Ultimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-11
- Decision date
- 2006-11-29
- Days to decision
- 79 days
- Clearance type
- Traditional
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Ma recall (Z-1217-2010) | Ulti Med, Inc. | 2010-03-31 |