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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Metal, Fiberoptic
510(k) Number K771181
Device Name VAGINAL ILLUMINATOR, MODEL 78570
Applicant
Welch Allyn, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Welch Allyn, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.4520
Classification Product Code
HDG  
Date Received06/30/1977
Decision Date 07/14/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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