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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 K160172
FOIA Releasable 510(k) K160172
Device Name Laparoscope Lens Shield Device
Applicant
Medeon Biodesign, Inc.
7f, 116, Hougang St.,
Taipei,  TW 11170
Applicant Contact Greta Chang
Correspondent
Medeon Biodesign, Inc.
7f, 116, Hougang St.,
Taipei,  TW 11170
Correspondent Contact Greta Chang
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/27/2016
Decision Date 04/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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