The following data is part of a premarket notification filed by Colbar Lifescience Ltd. with the FDA for Ossix -plus.
| Device ID | K053260 |
| 510k Number | K053260 |
| Device Name: | OSSIX -PLUS |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | COLBAR LIFESCIENCE LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan COLBAR LIFESCIENCE LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-22 |
| Decision Date | 2006-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290015477765 | K053260 | 000 |
| 07290015477727 | K053260 | 000 |
| 07290015477710 | K053260 | 000 |