The following data is part of a premarket notification filed by Het Systems, Llc with the FDA for Het Bipolar Ligator System.
| Device ID | K121085 |
| 510k Number | K121085 |
| Device Name: | HET BIPOLAR LIGATOR SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HET SYSTEMS, LLC 1152 NAVARRO ST, STE 2001 Santa Rosa, CA 95401 |
| Contact | Shelley Trimm |
| Correspondent | Shelley Trimm HET SYSTEMS, LLC 1152 NAVARRO ST, STE 2001 Santa Rosa, CA 95401 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-10 |
| Decision Date | 2012-11-20 |
| Summary: | summary |