510(k) K142640
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator by
Bio Compression Systems, Inc.
— Product Code JOW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2014
- Date Received
- September 17, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type