The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Neuro-fiberscope.
| Device ID | K002788 |
| 510k Number | K002788 |
| Device Name: | KSEA NEURO-FIBERSCOPE |
| Classification | Endoscope, Neurological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan 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 | 2000-09-07 |
| Decision Date | 2000-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551226476 | K002788 | 000 |