510(k) K891673
K891673 is an FDA 510(k) premarket notification submitted by Waters Chemical Products for the device "ADVANCED PURIFICATION GLASS COLUMN". The FDA issued a decision of Substantially Equivalent on April 26, 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
- April 26, 1989
- Date Received
- March 21, 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