MICROCAPILLARY INFUSION SYSTEM
FDA 510(k) clearance K831347 · decided 1983-06-02
Clearance details
- K-number
- K831347
- Device name
- MICROCAPILLARY INFUSION SYSTEM
- Applicant
- J.S. Biomedicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-25
- Decision date
- 1983-06-02
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- FFX
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.