Proxenon 350, Model 902XX
FDA 510(k) K071218 · Welch Allyn, Inc.
510(k) numberK071218
Submission
- Device name
- Proxenon 350, Model 902XX
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- May 2, 2007
- Decision date
- June 14, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Proxenon 350, Model 902XX cleared by the FDA?
Proxenon 350, Model 902XX (K071218) received a 510(k) decision of Substantially Equivalent on June 14, 2007, 43 days after the submission was received.
What is the product code of K071218?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.