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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 K954864
Device Name ASLAN MODULAR INSTRUMENT
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
GCJ  
Date Received10/23/1995
Decision Date 02/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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