510(k) K123820
K123820 is an FDA 510(k) premarket notification submitted by Bossong Hosiery Mills, Inc. for the device "BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS". The FDA issued a decision of Substantially Equivalent on April 2, 2013. 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
- April 2, 2013
- Date Received
- December 12, 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