The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Cytrans Granules.
| Device ID | K192597 |
| 510k Number | K192597 |
| Device Name: | Cytrans Granules |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | GC America, Inc. 3737 W. 127th St. Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | H. Carl Jenkins Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff, IL 60045 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2020-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470143641 | K192597 | 000 |
| 14548161312141 | K192597 | 000 |
| 14548161312158 | K192597 | 000 |
| 14548161312165 | K192597 | 000 |
| 14548161312172 | K192597 | 000 |
| 04548161312137 | K192597 | 000 |
| 04548161312144 | K192597 | 000 |
| 04548161312151 | K192597 | 000 |
| 04548161312168 | K192597 | 000 |
| 04548161312175 | K192597 | 000 |
| D0470143601 | K192597 | 000 |
| D0470143611 | K192597 | 000 |
| D0470143621 | K192597 | 000 |
| D0470143631 | K192597 | 000 |
| 14548161312134 | K192597 | 000 |