The following data is part of a premarket notification filed by Palette Life Sciences with the FDA for Barrigel Injectable Gel.
| Device ID | K220641 |
| 510k Number | K220641 |
| Device Name: | Barrigel Injectable Gel |
| Classification | Hydrogel Spacer |
| Applicant | Palette Life Sciences 27 East Cota Street, Suite 402 Santa Barbara, CA 93101 |
| Contact | David Goodnough |
| Correspondent | David Goodnough Palette Life Sciences 27 East Cota Street, Suite 402 Santa Barbara, CA 93101 |
| Product Code | OVB |
| CFR Regulation Number | 892.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004725115 | K220641 | 000 |
| 00850004725108 | K220641 | 000 |
| 00850004725139 | K220641 | 000 |