SunCHECK
Accelerator, Linear, Medical
SUN NUCLEAR CORPORATION
The following data is part of a premarket notification filed by Sun Nuclear Corporation with the FDA for Suncheck.
Pre-market Notification Details
| Device ID | K170307 |
| 510k Number | K170307 |
| Device Name: | SunCHECK |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORPORATION 3275 SUNTREE BLVD. Melbourne, FL 32940 |
| Contact | Rene Hardee |
| Correspondent | Rene Hardee SUN NUCLEAR CORPORATION 3275 SUNTREE BLVD. 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 | 2017-02-01 |
| Decision Date | 2017-10-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060608880348 | K170307 | 000 |
Trademark Results [SunCHECK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUNCHECK 87826627 not registered Live/Pending |
SUN NUCLEAR CORP. 2018-03-08 |
 SUNCHECK 78814172 3258013 Dead/Cancelled |
Inno-Via, LLC 2006-02-14 |
 SUNCHECK 74209855 1937640 Dead/Cancelled |
Sherwood Skincare Limited 1991-10-07 |
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