510(k) K943348
K943348 is an FDA 510(k) premarket notification submitted by Patton, Boggs & Blow for the device "KLS CHIN PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 4, 1994. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Patton, Boggs & Blow has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1994
- Date Received
- July 12, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type