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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscopy Kit
510(k) Number K950924
Device Name ASLAN KNOT PUSHER
Applicant
Aslan Medical Technologies, Ltd.
6376 Quail Run Dr.
Kalamazoo,  MI  49009
Applicant Contact THOMAS J HOOGEBOOM
Correspondent
Aslan Medical Technologies, Ltd.
6376 Quail Run Dr.
Kalamazoo,  MI  49009
Correspondent Contact THOMAS J HOOGEBOOM
Regulation Number876.1500
Classification Product Code
FDE  
Date Received03/01/1995
Decision Date 03/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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