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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 K140662
Device Name FLEX ENDOSCOPIC INSTRUMENTS
Applicant
Design Standards Corp.
128 Blye Hill Landing
Newbury,  NH  03255
Applicant Contact MICHELE LUCEY
Correspondent
Design Standards Corp.
128 Blye Hill Landing
Newbury,  NH  03255
Correspondent Contact MICHELE LUCEY
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
GEI   GEX  
Date Received03/14/2014
Decision Date 06/11/2014
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
Predetermined Change
Control Plan Authorized		 No
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