Detachatip III Plus Instrument Tray Model 3-4343
FDA 510(k) K123175 · Conmed Corporation
510(k) numberK123175
Submission
- Device name
- Detachatip III Plus Instrument Tray Model 3-4343
- Applicant
- Conmed Corporation
Utica, NY, US - Received
- October 9, 2012
- Decision date
- February 21, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
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Questions and answers
When was Detachatip III Plus Instrument Tray Model 3-4343 cleared by the FDA?
Detachatip III Plus Instrument Tray Model 3-4343 (K123175) received a 510(k) decision of Substantially Equivalent on February 21, 2013, 135 days after the submission was received.
What is the product code of K123175?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.