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 |