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 |