VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
FDA 510(k) clearance K031748 · decided 2003-08-27
Clearance details
- K-number
- K031748
- Device name
- VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
- Applicant
- Vitalcare Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-05
- Decision date
- 2003-08-27
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.