510(k) K092892

1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 by I-Ming Sanitary Materials Co., Ltd. — Product Code DWL

K092892 is an FDA 510(k) premarket notification submitted by I-Ming Sanitary Materials Co., Ltd. for the device "1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613". The FDA issued a decision of Substantially Equivalent on August 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
August 3, 2010
Date Received
September 21, 2009
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