510(k) K123561
K123561 is an FDA 510(k) premarket notification submitted by Bsn Medical, Inc. for the device "ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS". The FDA issued a decision of Substantially Equivalent on December 18, 2012. 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. Bsn Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2012
- Date Received
- November 19, 2012
- Clearance Type
- Special
- 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