510(k) K143166
K143166 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings (Dba Medline Renewal for the device "Medline ReNewal Reprocessed Compression Limb Sleeves". The FDA issued a decision of Substantially Equivalent on January 16, 2015. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Surgical Instrument Service and Savings (Dba Medline Renewal has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2015
- Date Received
- November 4, 2014
- Clearance Type
- Special
- 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