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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, partial ossicular replacement
510(k) Number K760437
Device Name CAUSSE MODIFIED TEFLON PISTON, OTOLOGY
Applicant
RICHARD'S MEDICAL EQUIP., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RICHARD'S MEDICAL EQUIP., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.3450
Classification Product Code
ETB  
Date Received08/16/1976
Decision Date 10/05/1976
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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