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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coagulator, culdoscopic (and accessories)
510(k) Number K151567
Device Name ENDOPLUS hand-held laparoscopic instruments
750 Tower Road, Suite A
Mundelein,  IL  60060
Applicant Contact Matthew Gudeman
Smith Assoicates
1468 Harwell Avenue
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number884.4160
Classification Product Code
Date Received06/10/2015
Decision Date 12/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No