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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 K960710
Device Name CONDOM
Applicant
POLAR LATEX LTD.
P.O. BOX 1673
JULIAN,  CA  92036
Applicant Contact JULIA ERICKSON
Correspondent
POLAR LATEX LTD.
P.O. BOX 1673
JULIAN,  CA  92036
Correspondent Contact JULIA ERICKSON
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/21/1996
Decision Date 10/10/1996
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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