The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc with the FDA for Karl Storz Uromat E.a.s.i..
| Device ID | K162992 |
| 510k Number | K162992 |
| Device Name: | Karl Storz UROMAT E.A.S.I. |
| Classification | System, Irrigation, Urological |
| Applicant | KARL STORZ ENDOSCOPY AMERICA, INC 2151 E. GRAND AVENUE El Segundo, CA 90245 |
| Contact | Serkan Sezer |
| Correspondent | Jack Rogers SAFIS SOLUTIONS LLC 303 N. ALABAMA SUITE 210 Indianapolis, IN 46204 -2132 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-27 |
| Decision Date | 2017-07-07 |
| Summary: | summary |