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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 K820564
Device Name WORLD'S BEST (CONTRACEPTIVE)
Applicant
ROSEN KILDE STENHOJ
4221 Richmond Rd., N.W.
walker,  MI  49534
Correspondent
ROSEN KILDE STENHOJ
4221 Richmond Rd., N.W.
walker,  MI  49534
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/02/1982
Decision Date 05/28/1982
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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