The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Clearvision Ii, Model 40334120.
| Device ID | K072410 |
| 510k Number | K072410 |
| Device Name: | KSEA CLEARVISION II, MODEL 40334120 |
| Classification | Endoscope, Neurological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Crystal Dizol |
| Correspondent | Crystal Dizol KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-27 |
| Decision Date | 2008-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551102169 | K072410 | 000 |
| 04048551102145 | K072410 | 000 |