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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 K850240
Device Name KM PRODUCTS SUCTION TIPS
Applicant
Km Products
1349 W. Allegheny
Tucson,  AZ  85705
Applicant Contact ALAN R KENT
Correspondent
Km Products
1349 W. Allegheny
Tucson,  AZ  85705
Correspondent Contact ALAN R KENT
Regulation Number880.6740
Classification Product Code
JOL  
Date Received01/22/1985
Decision Date 03/06/1985
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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