510(k) K895105
K895105 is an FDA 510(k) premarket notification submitted by Waters Chemical Products for the device "HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code DPM (Columns, Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Waters Chemical Products has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1989
- Date Received
- August 15, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Columns, Liquid Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2260
- Review Panel
- TX
- Submission Type