PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
FDA 510(k) clearance K993058 · decided 2000-01-24
Clearance details
- K-number
- K993058
- Device name
- PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
- Applicant
- Pure Water, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-13
- Decision date
- 2000-01-24
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- FIN
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Anderson, SC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.