510(k) K945575
K945575 is an FDA 510(k) premarket notification submitted by Cottrell, Ltd. for the device "PRO BARRIER(TM) TUBE SOX(TM)". The FDA issued a decision of Substantially Equivalent on March 6, 1995. Cottrell, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1995
- Date Received
- November 14, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No