MAINSTREAM WATER PURIFICATION DEVICE— 510(k) K012716
Substantially EquivalentPrismedical Corp.
FDA 510(k) clearance K012716 for MAINSTREAM WATER PURIFICATION DEVICE, Substantially Equivalent on 2002-05-07. Applicant: Prismedical Corp.. Device class: 2.
Clearance details
- Applicant
- Prismedical Corp.
- Product code
- Code NHV
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Napa, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.