CoolSeal Reveal
Electrosurgical, Cutting & Coagulation & Accessories
Bolder Surgical, LLC
The following data is part of a premarket notification filed by Bolder Surgical, Llc with the FDA for Coolseal Reveal.
Pre-market Notification Details
| Device ID | K203640 |
| 510k Number | K203640 |
| Device Name: | CoolSeal Reveal |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Bolder Surgical, LLC 331 S. 104th Street, Suite 200 Louisville, CO 80027 |
| Contact | Nicholas Wong |
| Correspondent | Nicholas Wong Bolder Surgical, LLC 331 S. 104th Street, Suite 200 Louisville, CO 80027 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-14 |
| Decision Date | 2021-05-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850346007099 | K203640 | 000 |
Trademark Results [CoolSeal Reveal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COOLSEAL REVEAL 90760861 not registered Live/Pending |
Bolder Surgical, LLC 2021-06-08 |
 COOLSEAL REVEAL 88656731 not registered Live/Pending |
JustRight Surgical, LLC 2019-10-16 |
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