510(k) K854428
K854428 is an FDA 510(k) premarket notification submitted by Barton-Carey Medical Products Co. for the device "VASC-EZ". The FDA issued a decision of Substantially Equivalent on Feb 13, 1986. The device falls under product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)), a Class II device regulated under 21 CFR 880.5780.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 1986
- Date Received
- Nov 5, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- Device Class
- Class II
- Regulation Number
- 880.5780
- Review Panel
- HO
- Submission Type
- 510(k) Exempt