510(k) K832595
K832595 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "VESSEL DILATOR". The FDA issued a decision of Substantially Equivalent on August 31, 1983. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1983
- Date Received
- August 2, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, Surgical
- Device Class
- Class II
- Regulation Number
- 870.4475
- Review Panel
- CV
- Submission Type