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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 K023222
Device Name ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12
Applicant
Invitrocare, Inc.
8415 Progress Dr.
Suite F
Frederick,  MD  21701
Applicant Contact ROBERT E LOVINS
Correspondent
Invitrocare, Inc.
8415 Progress Dr.
Suite F
Frederick,  MD  21701
Correspondent Contact ROBERT E LOVINS
Regulation Number884.6180
Classification Product Code
MQL  
Date Received09/27/2002
Decision Date 12/26/2002
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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