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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K991022
Device Name SPERM WASHING MEDIA
Applicant
<Genx> Intl., Inc.
170 Fort Path Rd.
Unit 14
Madison,  CT  06443
Applicant Contact MICHAEL D CECCHI
Correspondent
Intl., Inc.
170 Fort Path Rd.
Unit 14
Madison,  CT  06443
Correspondent Contact MICHAEL D CECCHI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received03/29/1999
Decision Date 09/09/1999
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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