510(k) K851651

HGM ENDOCOAGULATOR MODEL 8 by Hgm, Inc.

K851651 is an FDA 510(k) premarket notification submitted by Hgm, Inc. for the device "HGM ENDOCOAGULATOR MODEL 8". The FDA issued a decision of Substantially Equivalent on July 23, 1985. Hgm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1985
Date Received
April 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No