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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K962816
Device Name SPERM PREPARATION MEDIA
Applicant
Genx Intl., Inc.
339 Bartlett Dr.
Madison,  CT  06443
Applicant Contact MICHAEL D CECCHI
Correspondent
Genx Intl., Inc.
339 Bartlett Dr.
Madison,  CT  06443
Correspondent Contact MICHAEL D CECCHI
Regulation Number884.5300
Classification Product Code
MOL  
Date Received07/19/1996
Decision Date 11/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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