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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K002094
Device Name BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
Applicant
C.R. BARD, INC.
129 CONCORD RD., BLDG. #3
BILLERICA,  MA  01821
Applicant Contact MARION GORDON
Correspondent
C.R. BARD, INC.
129 CONCORD RD., BLDG. #3
BILLERICA,  MA  01821
Correspondent Contact MARION GORDON
Regulation Number878.3610
Classification Product Code
ESW  
Date Received07/11/2000
Decision Date 10/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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