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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 K013835
Device Name GLOBAL HEALTHCARE VAGINAL SPECULUM
Applicant
Dynascend Consulting Int'L, LLC
1144 Canton St., Suite 103
Roswell,  GA  30075
Applicant Contact ALAM AHMED
Correspondent
Dynascend Consulting Int'L, LLC
1144 Canton St., Suite 103
Roswell,  GA  30075
Correspondent Contact ALAM AHMED
Regulation Number884.4530
Classification Product Code
HIB  
Date Received11/19/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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