510(k) K050337
K050337 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "SIS FISTULA PLUG". The FDA issued a decision of Substantially Equivalent on March 9, 2005. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2005
- Date Received
- February 10, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type