The following data is part of a premarket notification filed by Skeletal Kinetics, Llc with the FDA for Callos.
| Device ID | K030554 |
| 510k Number | K030554 |
| Device Name: | CALLOS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SKELETAL KINETICS, LLC 555 13TH ST. N.W. Washington, DC 20004 |
| Contact | Howard Holstein |
| Correspondent | Howard Holstein SKELETAL KINETICS, LLC 555 13TH ST. N.W. Washington, DC 20004 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-21 |
| Decision Date | 2003-05-20 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CALLOS 86717818 not registered Dead/Abandoned |
Foley Family Wines, Inc. 2015-08-07 |
![]() CALLOS 76470168 2929312 Live/Registered |
SK RESEARCH AND DEVELOPMENT, LLC 2002-11-25 |