510(k) K994328
K994328 is an FDA 510(k) premarket notification submitted by Genzyme Corp. for the device "SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX". The FDA issued a decision of Substantially Equivalent on March 2, 2000. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Genzyme Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2000
- Date Received
- December 22, 1999
- 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