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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K851981
Device Name NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.
Applicant
SUPERIOR PLASTIC PRODUCTS CORP.
COLUMBIA INDUSTRIAL PARK
CUMBERLAND,  RI  02864
Applicant Contact PAUL BERNARD
Correspondent
SUPERIOR PLASTIC PRODUCTS CORP.
COLUMBIA INDUSTRIAL PARK
CUMBERLAND,  RI  02864
Correspondent Contact PAUL BERNARD
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/07/1985
Decision Date 06/18/1985
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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