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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K852913
Device Name HGM ENDOCOAGULATOR MODEL 20
Applicant
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact JEROME STENEHJEM
Correspondent
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact JEROME STENEHJEM
Date Received07/11/1985
Decision Date 09/05/1985
Decision Substantially Equivalent (SESE)
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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