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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 K132390
Device Name INSTINCT; PLAIN, DOTTED, ULTRA THIN
Applicant
PROFILATEX, S.A. DE C.V.
FEBRERO DE 1917 #4
COL. CIPRESES
CHALCO,  MX 56600
Applicant Contact JUAN ERNESTO DE LA PUENTE
Correspondent
PROFILATEX, S.A. DE C.V.
FEBRERO DE 1917 #4
COL. CIPRESES
CHALCO,  MX 56600
Correspondent Contact JUAN ERNESTO DE LA PUENTE
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/01/2013
Decision Date 04/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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