The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Univ Irrigat/aspira & Phacoemulsifcation Pac.
| Device ID | K882240 |
| 510k Number | K882240 |
| Device Name: | STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Dan Regan |
| Correspondent | Dan Regan STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-27 |
| Decision Date | 1988-07-29 |