510(k) K973955
K973955 is an FDA 510(k) premarket notification submitted by Herniamesh for the device "HERNIAMESH SURGICAL MESHES". The FDA issued a decision of Substantially Equivalent on May 11, 1998. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Herniamesh has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1998
- Date Received
- October 16, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type