510(k) K020333
K020333 is an FDA 510(k) premarket notification submitted by Atrion Medical Products, Inc. for the device "ATRION MEDICAL QL FLUID DISPENSING SYRINGE". The FDA issued a decision of Substantially Equivalent on April 25, 2002. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Atrion Medical Products, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2002
- Date Received
- January 31, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type