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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, Nonmetal
510(k) Number K000414
Device Name MEDISUL DISPOSABLE VAGINAL SPECULUM
Applicant
Marketing Perspectives
6565 146th Ave.
Holland,  MI  49423
Applicant Contact JIMMIE D WILSON
Correspondent
Marketing Perspectives
6565 146th Ave.
Holland,  MI  49423
Correspondent Contact JIMMIE D WILSON
Regulation Number884.4530
Classification Product Code
HIB  
Date Received02/08/2000
Decision Date 04/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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