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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name otoscope
510(k) Number K831709
Device Name AUDIOSCOPE #23000 W/71123 CHARGING STAND
Applicant
WELCH ALLYN, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
WELCH ALLYN, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4770
Classification Product Code
ERA  
Date Received05/26/1983
Decision Date 06/30/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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