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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sigmoidoscope and accessories, flexible/rigid
510(k) Number K770291
Device Name SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125
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 Number876.1500
Classification Product Code
FAM  
Date Received02/14/1977
Decision Date 02/18/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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