510(k) K091380
K091380 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "CORDCAP". The FDA issued a decision of Substantially Equivalent on July 30, 2009. The device falls under product code MVL (Cord, Retraction), a Class U device. Centrix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2009
- Date Received
- May 11, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cord, Retraction
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type