510(k) K072076
K072076 is an FDA 510(k) premarket notification submitted by Osteogenics Biomedical, Inc. for the device "CYTOPLAST PTFE SUTURE". The FDA issued a decision of Substantially Equivalent on October 31, 2007. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035. Osteogenics Biomedical, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2007
- Date Received
- July 30, 2007
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Device Class
- Class II
- Regulation Number
- 878.5035
- Review Panel
- SU
- Submission Type