The following data is part of a premarket notification filed by Storz with the FDA for Storz Microflow Phacoemulsification Needle.
| Device ID | K954340 |
| 510k Number | K954340 |
| Device Name: | STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE |
| Classification | Unit, Phacofragmentation |
| Applicant | STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
| Contact | Audrey Swearingen |
| Correspondent | Audrey Swearingen STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1995-12-14 |