510(k) K930015
K930015 is an FDA 510(k) premarket notification submitted by Stony Brook Surgical Innovations, Inc. for the device "STERNAL BAND". The FDA issued a decision of Substantially Equivalent on May 19, 1993. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Stony Brook Surgical Innovations, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 1993
- Date Received
- January 4, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type