The following data is part of a premarket notification filed by Het Systems, Llc with the FDA for Het Systems, Llc, Het Bipolar Ligator System.
| Device ID | K140422 |
| 510k Number | K140422 |
| Device Name: | HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HET SYSTEMS, LLC 200 MIDDLESEX TURNPIKE SUITE 304 Iselin, NJ 08830 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer HET SYSTEMS, LLC 200 MIDDLESEX TURNPIKE SUITE 304 Iselin, NJ 08830 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521511170 | K140422 | 000 |
| 10884521511149 | K140422 | 000 |
| 20884521511139 | K140422 | 000 |
| 10884521539792 | K140422 | 000 |
| 10884521511156 | K140422 | 000 |