510(k) K931182
K931182 is an FDA 510(k) premarket notification submitted by Vesitec Medical, Inc. for the device "VESITEC DRILL GUIDE". The FDA issued a decision of Substantially Equivalent on June 9, 1993. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Vesitec Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1993
- Date Received
- March 9, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type