The following data is part of a premarket notification filed by Het Systems, Llc with the FDA for Het Bipolar Electrocautery Forceps.
| Device ID | K110143 |
| 510k Number | K110143 |
| Device Name: | HET BIPOLAR ELECTROCAUTERY FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HET SYSTEMS, LLC 1502 E 14TH STREET SUITE 2 Brooklyn, NY 11230 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer HET SYSTEMS, LLC 1502 E 14TH STREET SUITE 2 Brooklyn, NY 11230 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-06-02 |
| Summary: | summary |