510(k) K101224
K101224 is an FDA 510(k) premarket notification submitted by Griffiths and Nielsen, Ltd. for the device "SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS". The FDA issued a decision of Substantially Equivalent on December 3, 2010. 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
- December 3, 2010
- Date Received
- May 3, 2010
- 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