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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal, Long-Term Indwelling
510(k) Number K934610
Device Name CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS
Applicant
Tabex Industries, Inc.
5050 Poplar Av.
Suite 732
Memphis,  TN  38157
Applicant Contact PHILIP W FENTRESS
Correspondent
Tabex Industries, Inc.
5050 Poplar Av.
Suite 732
Memphis,  TN  38157
Correspondent Contact PHILIP W FENTRESS
Regulation Number876.5630
Classification Product Code
FJS  
Date Received09/27/1993
Decision Date 09/23/1994
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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