The following data is part of a premarket notification filed by Energist, Ltd. with the FDA for Neogen Psr System.
| Device ID | K132754 |
| 510k Number | K132754 |
| Device Name: | NEOGEN PSR SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENERGIST, LTD. 2 PARK PAVILIONS, CLOS LLYN CWM ENTERPRISE PARK Swansea, GB Sa6 8qy |
| Contact | Darren Thomas |
| Correspondent | Darren Thomas ENERGIST, LTD. 2 PARK PAVILIONS, CLOS LLYN CWM ENTERPRISE PARK Swansea, GB Sa6 8qy |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2013-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060440520099 | K132754 | 000 |
| 05060440520105 | K132754 | 000 |
| 05060440520129 | K132754 | 000 |
| 05060440520273 | K132754 | 000 |
| 05060440520280 | K132754 | 000 |
| 15060440520195 | K132754 | 000 |
| 15060440520201 | K132754 | 000 |
| 15060440520218 | K132754 | 000 |
| 15060440520225 | K132754 | 000 |
| 15060440520256 | K132754 | 000 |
| 15060440520263 | K132754 | 000 |
| 15060440520232 | K132754 | 000 |
| 15060440520249 | K132754 | 000 |
| 05060440520334 | K132754 | 000 |