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510(k) K111555

CIRCUMAURAL ADHESIVE REPLACEMENT by R & D Medical Products, Inc. — Product Code GWJ

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

Other clearances by R & D Medical Products, Inc.

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  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)