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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K973734
Device Name STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
Applicant
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Applicant Contact PAMELA PAPINEAU
Correspondent
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Correspondent Contact PAMELA PAPINEAU
Regulation Number880.6740
Classification Product Code
JOL  
Date Received09/30/1997
Decision Date 02/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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