The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Medi Pack.
| Device ID | K022490 |
| 510k Number | K022490 |
| Device Name: | KSEA MEDI PACK |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Contact | James A Lee |
| Correspondent | James A Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-29 |
| Decision Date | 2003-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551322925 | K022490 | 000 |
| 04048551006689 | K022490 | 000 |