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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 K062425
Device Name LIFECATH S PICC AND MIDLINE CATHETER
Applicant
VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN,  PA  19403
Applicant Contact COURTNEY SMITH
Correspondent
VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN,  PA  19403
Correspondent Contact COURTNEY SMITH
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/18/2006
Decision Date 09/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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