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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 K051690
Device Name VYGON NUTRILINE CATHETERS
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 Received06/23/2005
Decision Date 08/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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