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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 K022332
Device Name LITE MINERAL OIL
Applicant
<GENX> INTL., INC.
393 SOUNDVIEW RD.
GUILFORD,  CT  06443
Applicant Contact MICHAEL D CECCHI
Correspondent
INTL., INC.
393 SOUNDVIEW RD.
GUILFORD,  CT  06443
Correspondent Contact MICHAEL D CECCHI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/18/2002
Decision Date 08/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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