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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 K070705
Device Name MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
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 Jay F W
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/14/2007
Decision Date 11/30/2007
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
Recalls CDRH Recalls
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