The following data is part of a premarket notification filed by Green Or, Llc. with the FDA for Green Or Reprocessed Aquamantys Bipolar Sealer.
| Device ID | K211203 |
| 510k Number | K211203 |
| Device Name: | Green OR Reprocessed Aquamantys Bipolar Sealer |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | Green OR, LLC. 4200 Dahlberg Drive #300 Golden Valley, MN 55422 |
| Contact | John Zehren |
| Correspondent | Aaron Rogers Pathway LLC 8779 Cottonwood Ave, Suite 105 Santee, CA 92071 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-22 |
| Decision Date | 2022-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850043377108 | K211203 | 000 |
| 00850043377092 | K211203 | 000 |
| 00850043377085 | K211203 | 000 |
| 00850043377023 | K211203 | 000 |
| 00850043377016 | K211203 | 000 |
| 00850043377009 | K211203 | 000 |