GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
FDA 510(k) clearance K974899 · decided 1998-09-23
Clearance details
- K-number
- K974899
- Device name
- GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
- Applicant
- Gambro Healthcare
- Decision
- Substantially Equivalent
- Date received
- 1997-12-30
- Decision date
- 1998-09-23
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- FIP
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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