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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 K011480
Device Name VIVA
Applicant
RICHTER RUBBER TECHNOLOGY SDN. BHD.
BOX 32222
LOUISVILLE,  KY  40232
Applicant Contact FRANK C SADLO
Correspondent
RICHTER RUBBER TECHNOLOGY SDN. BHD.
BOX 32222
LOUISVILLE,  KY  40232
Correspondent Contact FRANK C SADLO
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/14/2001
Decision Date 05/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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