510(k) K123085
K123085 is an FDA 510(k) premarket notification submitted by 3M Company for the device "FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE". The FDA issued a decision of Substantially Equivalent on December 20, 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. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2012
- Date Received
- October 1, 2012
- 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