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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K864963
Device Name STOMACH EVACULATOR - EWALD STYLE
Applicant
Medovations, Inc.
102 E. Keefe Ave.
Milwaukee,  WI  53212
Applicant Contact LARRY R PIERCE
Correspondent
Medovations, Inc.
102 E. Keefe Ave.
Milwaukee,  WI  53212
Correspondent Contact LARRY R PIERCE
Regulation Number876.4730
Classification Product Code
KOA  
Date Received12/22/1986
Decision Date 10/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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