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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 K922714
Device Name UNIVERSAL IRRIGATION & SUCTION TUBING SET
Applicant
Ximed Medical Systems
2344-A Walsh Ave.
Santa Clara,  CA  95051
Applicant Contact ASHVIN DESAI
Correspondent
Ximed Medical Systems
2344-A Walsh Ave.
Santa Clara,  CA  95051
Correspondent Contact ASHVIN DESAI
Regulation Number880.6740
Classification Product Code
JOL  
Date Received06/05/1992
Decision Date 08/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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