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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K982287
Device Name ASLAN SENSOR MODULAR INSTRUMENT
Applicant
ASLAN MEDICAL TECHNOLOGIES, LTD.
4110 SOUTH 9TH ST.
KALAMAZOO,  MI  49009 -8120
Applicant Contact THOMAS J HOOGEBOOM
Correspondent
ASLAN MEDICAL TECHNOLOGIES, LTD.
4110 SOUTH 9TH ST.
KALAMAZOO,  MI  49009 -8120
Correspondent Contact THOMAS J HOOGEBOOM
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/30/1998
Decision Date 08/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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