The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Stotz Protege(tm) Microsurgical System.
| Device ID | K950114 |
| 510k Number | K950114 |
| Device Name: | STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Michael H Southworth |
| Correspondent | Michael H Southworth STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-11 |
| Decision Date | 1995-06-02 |