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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 K901111
Device Name NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
Applicant
ANSELL, INC.
INDUSTRIAL RD.
POST OFFICE BOX 1252
DOTHAN,  AL  36302
Applicant Contact P. K REDDY
Correspondent
ANSELL, INC.
INDUSTRIAL RD.
POST OFFICE BOX 1252
DOTHAN,  AL  36302
Correspondent Contact P. K REDDY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/09/1990
Decision Date 03/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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