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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Culture, Ex Vivo, Tissue And Cell
510(k) Number K022086
Device Name AIM-V (R) MEDIUM, MODEL 087-0112
Applicant
Invitrogen Corporation
3175 Staley Rd.
Grand Island,  NY  14072
Applicant Contact KEITH D GITTERMAN
Correspondent
Invitrogen Corporation
3175 Staley Rd.
Grand Island,  NY  14072
Correspondent Contact KEITH D GITTERMAN
Regulation Number876.5885
Classification Product Code
NDS  
Date Received06/27/2002
Decision Date 12/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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