Targobeam
FDA 510(k) K970819 · Ferguson Medical
510(k) numberK970819
Submission
- Device name
- Targobeam
- Applicant
- Ferguson Medical
Chico, CA, US - Received
- March 5, 1997
- Decision date
- July 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K970280 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam…HSB · Traditional | 05/22/1997SE |
| K970258 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…HRS · Traditional | 05/22/1997SE |
| K970257 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian…HSB · Traditional | 05/22/1997SE |
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Questions and answers
When was Targobeam cleared by the FDA?
Targobeam (K970819) received a 510(k) decision of Substantially Equivalent on July 14, 1997, 131 days after the submission was received.
What is the product code of K970819?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.