The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Dp4210 Venturi Economy Anterior Pack And Dp5000 Asc Daypack.
| Device ID | K980100 |
| 510k Number | K980100 |
| Device Name: | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK |
| Classification | Tubing, Replacement, Phacofragmentation Unit |
| 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 | MSR |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-12 |
| Decision Date | 1998-06-01 |
| Summary: | summary |