510(k) K221873
- Device
- NeoGen PSR System
- Applicant
- Energist Limited
- 510(k) number
- K221873
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-12
- Date received
- 2022-06-28
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Graham Booth
- Address
- 2 Park Pavilions, Clos Llyn Cwm Enterprise Park Swansea GB SA6 8QY SA6 8QY
FDA Registration Numbers#
- 1926681
- 9614434
- 3014461810
- 3006716777
- 3007748793
- 3027339877
- 3007029079
- 3015539532
- 3027339887
- 1720747
- 3003418325
- 3011625895
- 3017210488
- 1720929
- 8010298
- 1718850
- 3009763019
- 3006059917
- 3013188547
- 3007712511
- 3016813690
- 3033524168
- 8010591
- 3010226575
- 3044156918
- 3015895145
- 3010305275
- 3010288205
- 3013111980
- 3010816547
- 8030967
- 3010173425
- 3013438730
- 9617070
- 1222780
- 9680357
- 3010356635
- 3004754983
- 2031093
- 3013077751
- 3010621964
- 3014982808
- 3038675429
- 1018233
- 3035642068
- 1060680
- 3009423112
- 3009183442
- 3009609358
- 3006498370
- 3006696607
- 8010877
- 2183785
- 3012510750
- 8010890
- 3012606445
- 3008132398
- 3015515531
- 3009513193
- 9616666
- 1225492
- 2648623
- 1211998
- 3009905888
- 3031240334
- 3015506965
- 3031571464
- 3030412764
- 3004111573
- 3028977843
- 3011879048
- 2183715
- 3015779311
- 3015449142
- 3015540957
- 2648666
- 3012616488
- 3005334138
- 3012995405
Source Documents#
Other 510(k) Records For Product Code GEI#
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