The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Scb/conmed Esu Interface Module, Model 20091522.
| Device ID | K080410 |
| 510k Number | K080410 |
| Device Name: | KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 |
| Classification | Endoscopic Central Control Unit |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Susie Chen |
| Correspondent | Susie Chen KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-14 |
| Decision Date | 2008-04-09 |
| Summary: | summary |