XP202
FDA 510(k) K161922 · 3M Deutschland GmbH
510(k) numberK161922
Submission
- Device name
- XP202
- Applicant
- 3M Deutschland GmbH
Seefeld, DE - Received
- July 13, 2016
- Decision date
- September 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was XP202 cleared by the FDA?
XP202 (K161922) received a 510(k) decision of Substantially Equivalent on September 1, 2016, 50 days after the submission was received.
What is the product code of K161922?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.