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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
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