Hu-Friedy Dental Cartridge Syringe
FDA 510(k) K120659 · Hu-Friedy Mfg. Co., LLC
510(k) numberK120659
Submission
- Device name
- Hu-Friedy Dental Cartridge Syringe
- Applicant
- Hu-Friedy Mfg. Co., LLC
Chicago, IL, US - Received
- March 5, 2012
- Decision date
- November 6, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K040671 | Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating SyringesEJI · Traditional | Anthogyr | 12/14/2004SE |
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Questions and answers
When was Hu-Friedy Dental Cartridge Syringe cleared by the FDA?
Hu-Friedy Dental Cartridge Syringe (K120659) received a 510(k) decision of Substantially Equivalent on November 6, 2012, 246 days after the submission was received.
What is the product code of K120659?
The FDA product code is EJI – Syringe, Cartridge, a Class II (moderate risk) device regulated under 21 CFR 872.6770.