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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K993737
Device Name MIGHTY MAN (DYNAMIC LINKERS)
Applicant
Medtech Products , Ltd.
S-59 20th St., Anna Nagar W.
Chennai,  IN 600 040
Applicant Contact A.V.K. REDDY
Correspondent
Medtech Products , Ltd.
S-59 20th St., Anna Nagar W.
Chennai,  IN 600 040
Correspondent Contact A.V.K. REDDY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/04/1999
Decision Date 03/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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