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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 K902324
Device Name TP AND DESIGN, CONDOM
Applicant
CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP.
LACKENBACH SIEGEL MARZULLO
ONE CHASE RD. PENTHOUSE SUITE
SCARSDALE,  NY  10583
Applicant Contact HOWARD N ARONSON
Correspondent
CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP.
LACKENBACH SIEGEL MARZULLO
ONE CHASE RD. PENTHOUSE SUITE
SCARSDALE,  NY  10583
Correspondent Contact HOWARD N ARONSON
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/24/1990
Decision Date 03/29/1991
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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