PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
FDA 510(k) clearance K030813 · decided 2003-05-30
Clearance details
- K-number
- K030813
- Device name
- PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
- Applicant
- Primary Care Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-14
- Decision date
- 2003-05-30
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Zephyrhills, FL, US
- Third-party review
- No
- Expedited review
- No
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