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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K944676
Device Name MRI'S ALL SILICONE FOLEY CATHETER
Applicant
Mri Manufacturing and Research, Inc.
2045 N. Forbes Blvd.
Suite 105
Tuscon,  AZ  85745
Applicant Contact PATRICK J LAMB
Correspondent
Mri Manufacturing and Research, Inc.
2045 N. Forbes Blvd.
Suite 105
Tuscon,  AZ  85745
Correspondent Contact PATRICK J LAMB
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/22/1994
Decision Date 04/05/1996
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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