Lockjaw 15 Minute Intermaxillary Fixation System,Model LJ100-00
FDA 510(k) K990212 · Doctor'S Research Group, Inc.
510(k) numberK990212
Submission
- Device name
- Lockjaw 15 Minute Intermaxillary Fixation System,Model LJ100-00
- Applicant
- Doctor'S Research Group, Inc.
Wolcott, CT, US - Received
- January 22, 1999
- Decision date
- September 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Lockjaw 15 Minute Intermaxillary Fixation System,Model LJ100-00 cleared by the FDA?
Lockjaw 15 Minute Intermaxillary Fixation System,Model LJ100-00 (K990212) received a 510(k) decision of Substantially Equivalent on September 14, 1999, 235 days after the submission was received.
What is the product code of K990212?
The FDA product code is DYX – Lock, Wire, And Ligature, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.4600.