R.L. Medical Twin Light Source
FDA 510(k) K842609 · Tridak Division of Indicon, Inc.
510(k) numberK842609
Submission
- Device name
- R.L. Medical Twin Light Source
- Applicant
- Tridak Division of Indicon, Inc.
Mchenry, IL, US - Received
- July 5, 1984
- Decision date
- August 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCW – Light Source, Fiberoptic, Routine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was R.L. Medical Twin Light Source cleared by the FDA?
R.L. Medical Twin Light Source (K842609) received a 510(k) decision of Substantially Equivalent on August 9, 1984, 35 days after the submission was received.
What is the product code of K842609?
The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.