The following data is part of a premarket notification filed by Scieran Technologies, Inc. with the FDA for Frag Commander.
| Device ID | K973749 |
| 510k Number | K973749 |
| Device Name: | FRAG COMMANDER |
| Classification | Unit, Phacofragmentation |
| Applicant | SCIERAN TECHNOLOGIES, INC. 27071 CABOT RD., SUITE 127 Laguna Hills, CA 92653 |
| Contact | Rod Ross |
| Correspondent | Rod Ross SCIERAN TECHNOLOGIES, INC. 27071 CABOT RD., SUITE 127 Laguna Hills, CA 92653 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-01 |
| Decision Date | 1997-12-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FRAG COMMANDER 75322316 2265495 Dead/Cancelled |
Scieran Technologies, Inc. 1997-07-10 |