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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 K151117
Device Name Laparoscope Lens Shield Device
Medeon Biodesign, Inc
7F, 116 Hougang St
Taipei,  TW 11170
Applicant Contact Greta Chang
Lin & Associate, LLC
9223 Cambridge Manor Court
Potomac,  MD  20854
Correspondent Contact GRETA CHANG
Regulation Number876.1500
Classification Product Code
Date Received04/27/2015
Decision Date 08/20/2015
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