FDA 510(k) Application Details - K912901

Device Classification Name Condom

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510(K) Number K912901
Device Name Condom
Applicant CARTER PRODUCTS
HALF ACRE RD.
CRANBURY, NJ US
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Contact STEPHEN KOLAKOWSKY
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Regulation Number 884.5300

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Classification Product Code HIS
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Date Received 07/02/1991
Decision Date 02/03/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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