STERILE CATHERIZATION PROCEDURE TRAYS
FDA 510(k) clearance K830359 · decided 1983-03-17
Clearance details
- K-number
- K830359
- Device name
- STERILE CATHERIZATION PROCEDURE TRAYS
- Applicant
- Welcon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-03
- Decision date
- 1983-03-17
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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