510(k) K111555
K111555 is an FDA 510(k) premarket notification submitted by R & D Medical Products, Inc. for the device "CIRCUMAURAL ADHESIVE REPLACEMENT". The FDA issued a decision of Substantially Equivalent on July 25, 2011. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. R & D Medical Products, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2011
- Date Received
- June 3, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Auditory, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1900
- Review Panel
- NE
- Submission Type