The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Storz Microseal Phacoemulsification Needles (importation).
| Device ID | K951824 |
| 510k Number | K951824 |
| Device Name: | STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) |
| Classification | Unit, Phacofragmentation |
| Applicant | NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
| Contact | Ken Kato |
| Correspondent | Ken Kato NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-20 |
| Decision Date | 1995-07-19 |