The following data is part of a premarket notification filed by Hill-med, Inc. with the FDA for Hm-88011 Solid State Electr Surgical Unit.
Device ID | K961473 |
510k Number | K961473 |
Device Name: | HM-88011 SOLID STATE ELECTR SURGICAL UNIT |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | HILL-MED, INC. 7217 N.W. 46TH ST. Miami, FL 33166 |
Contact | Ernesto Ackerman |
Correspondent | Ernesto Ackerman 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 | 1996-04-17 |
Decision Date | 1996-05-07 |