The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz E8010 Ergotec/premiere Adaptor.
| Device ID | K964743 |
| 510k Number | K964743 |
| Device Name: | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Patrick G Balsmann |
| Correspondent | Patrick G Balsmann STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-26 |
| Decision Date | 1997-02-03 |
| Summary: | summary |