The following data is part of a premarket notification filed by Hill-med, Inc. with the FDA for Hm-930 Electrosurgical Unit.
Device ID | K993991 |
510k Number | K993991 |
Device Name: | HM-930 ELECTROSURGICAL UNIT |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | HILL-MED, INC. 7217 N.W. 46TH ST. Miami, FL 33166 |
Contact | Jhoana Vasquez |
Correspondent | Jhoana Vasquez HILL-MED, INC. 7217 N.W. 46TH ST. Miami, FL 33166 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-24 |
Decision Date | 2000-05-30 |
Summary: | summary |