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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 K984189
Device Name ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER
Applicant
Maxxim Medical
1445 Flat Creek Rd.
Athens,  TX  75751
Applicant Contact EDDIE MONROE
Correspondent
Maxxim Medical
1445 Flat Creek Rd.
Athens,  TX  75751
Correspondent Contact EDDIE MONROE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/23/1998
Decision Date 05/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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