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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 K890407
Device Name THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION
Applicant
Circle Rubber Corp.
408 Frelinghuysen Ave.
P.O. Box 223
Newark,  NJ  07114
Applicant Contact MITSUO SAITO
Correspondent
Circle Rubber Corp.
408 Frelinghuysen Ave.
P.O. Box 223
Newark,  NJ  07114
Correspondent Contact MITSUO SAITO
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/24/1989
Decision Date 05/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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