PERFRACTION
Accelerator, Linear, Medical
SUN NUCLEAR CORPORATION
The following data is part of a premarket notification filed by Sun Nuclear Corporation with the FDA for Perfraction.
Pre-market Notification Details
| Device ID | K141800 |
| 510k Number | K141800 |
| Device Name: | PERFRACTION |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORPORATION 3275 SUNTREE BOULEVARD Melbourne, FL 32940 |
| Contact | Jeff Kapatoes |
| Correspondent | Jeff Kapatoes SUN NUCLEAR CORPORATION 3275 SUNTREE BOULEVARD Melbourne, FL 32940 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-03 |
| Decision Date | 2014-09-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01612150000Z0 | K141800 | 000 |
Trademark Results [PERFRACTION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERFRACTION 88574978 not registered Live/Pending |
Perfrax Inc. 2019-08-12 |
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