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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 K072509
Device Name PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY
Applicant
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact JEAN CALLOW
Correspondent
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact JEAN CALLOW
Regulation Number880.5970
Classification Product Code
LJS  
Date Received09/06/2007
Decision Date 11/26/2007
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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