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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 K812312
Device Name STERILE WATER 4OZ.
Applicant
Superior Plastic Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Superior Plastic Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6740
Classification Product Code
JOL  
Date Received08/17/1981
Decision Date 11/13/1981
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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