The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Genoss Collagen Membrane Model Gcm1020, Gcm3040 Total 6 Models.
| Device ID | K102307 |
| 510k Number | K102307 |
| Device Name: | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A Cypress, CA 90630 |
| Contact | Eunkyung Son |
| Correspondent | Eunkyung Son GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A Cypress, CA 90630 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-16 |
| Decision Date | 2011-05-04 |
| Summary: | summary |