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510(k) K934432

OTOVIEW ENDOSCOPY SYSTEM by Smith & Nephew Richards, Inc. — Product Code EWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1994
Date Received
September 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Audiometer Calibration
Device Class
Class I
Regulation Number
874.1080
Review Panel
EN
Submission Type

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  • K962808 — ILIZAROV EXTERNAL FIXATION SYSTEM (August 19, 1996)
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Other clearances for product code EWA

  • K780474 — AUDIOMETER CALIBRATOR MODEL RA 310 (March 30, 1978)