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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 K843469
Device Name PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-
Applicant
Zimmar Consulting , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Zimmar Consulting , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6740
Classification Product Code
JOL  
Date Received09/06/1984
Decision Date 11/19/1984
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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