510(k) K852913

HGM ENDOCOAGULATOR MODEL 20 by Hgm, Inc.

K852913 is an FDA 510(k) premarket notification submitted by Hgm, Inc. for the device "HGM ENDOCOAGULATOR MODEL 20". The FDA issued a decision of Substantially Equivalent on September 5, 1985. Hgm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1985
Date Received
July 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No