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 |