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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, Long-Term Greater Than 30 Days
510(k) Number K003110
Device Name MEDCOMP BIO-CATH CATHETER LINE
Applicant
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact FLORENCE A CAIKOSKI
Correspondent
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact FLORENCE A CAIKOSKI
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/04/2000
Decision Date 12/01/2000
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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