510(k) K030212
K030212 is an FDA 510(k) premarket notification submitted by Genzyme Biosurgery for the device "MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on March 27, 2003. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Genzyme Biosurgery has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2003
- Date Received
- January 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Absorbable, Polydioxanone
- Device Class
- Class II
- Regulation Number
- 878.4840
- Review Panel
- SU
- Submission Type