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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 K871020
Device Name KANGLE CONDOM
Applicant
LINDLEY COMPANY, INC.
224 EAST OLIVE AVE.
SUITE 305
BURBANK,  CA  91502
Applicant Contact LILY SHEN
Correspondent
LINDLEY COMPANY, INC.
224 EAST OLIVE AVE.
SUITE 305
BURBANK,  CA  91502
Correspondent Contact LILY SHEN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/16/1987
Decision Date 07/21/1987
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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