510(k) K852913
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