The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Endoscope Holder.
| Device ID | K990334 |
| 510k Number | K990334 |
| Device Name: | KSEA ENDOSCOPE HOLDER |
| Classification | Endoscope Holder |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin A Kennan |
| Correspondent | Kevin A Kennan KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | OCV |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-03 |
| Decision Date | 1999-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551410912 | K990334 | 000 |
| 04048551422335 | K990334 | 000 |
| 04048551422328 | K990334 | 000 |
| 04048551255902 | K990334 | 000 |