Circumaural Adhesive Replacement
FDA 510(k) K111555 · R & D Medical Products, Inc.
510(k) numberK111555
Submission
- Device name
- Circumaural Adhesive Replacement
- Applicant
- R & D Medical Products, Inc.
Lake Forest, CA, US - Received
- June 3, 2011
- Decision date
- July 25, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Circumaural Adhesive Replacement cleared by the FDA?
Circumaural Adhesive Replacement (K111555) received a 510(k) decision of Substantially Equivalent on July 25, 2011, 52 days after the submission was received.
What is the product code of K111555?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.