510(k) K013059
K013059 is an FDA 510(k) premarket notification submitted by Stony Brook Surgical Innovations, Inc. for the device "STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)". The FDA issued a decision of Substantially Equivalent on October 22, 2001. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Stony Brook Surgical Innovations, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2001
- Date Received
- September 11, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device Class
- Class II
- Regulation Number
- 878.4495
- Review Panel
- SU
- Submission Type