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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Transport, Kidney
510(k) Number K911577
Device Name HYPOTRANS MODEL 750
Applicant
Martin Mclane Medical
7317 El Cajon Blvd.
Suite 201
La Mesa,  CA  91941
Applicant Contact DEBRA MCQUILLEN
Correspondent
Martin Mclane Medical
7317 El Cajon Blvd.
Suite 201
La Mesa,  CA  91941
Correspondent Contact DEBRA MCQUILLEN
Regulation Number876.5880
Classification Product Code
KDK  
Date Received04/08/1991
Decision Date 07/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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