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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, hemodialysis, implanted
510(k) Number K070572
Device Name ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM
Applicant
ASH ACCESS TECHNOLOGY, INC.
3601 SAGAMORE PKWY N SUITE B
LAFAYETTE,  IN  47904
Applicant Contact ROLAND WINGER
Correspondent
ASH ACCESS TECHNOLOGY, INC.
3601 SAGAMORE PKWY N SUITE B
LAFAYETTE,  IN  47904
Correspondent Contact ROLAND WINGER
Regulation Number876.5540
Classification Product Code
MSD  
Date Received02/28/2007
Decision Date 06/26/2007
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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