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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 K971028
Device Name WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED
Applicant
Worlds-Best Gummivarefabrik A/S
15 Rudolfgaardsvej
Viby J.,  DK 8260
Applicant Contact CHRISTIAN HJORTH
Correspondent
Worlds-Best Gummivarefabrik A/S
15 Rudolfgaardsvej
Viby J.,  DK 8260
Correspondent Contact CHRISTIAN HJORTH
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received03/20/1997
Decision Date 03/02/1998
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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