The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Calcusplit.
| Device ID | K992114 |
| 510k Number | K992114 |
| Device Name: | KSEA CALCUSPLIT |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin A Kennan |
| Correspondent | Kevin A Kennan KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-22 |
| Decision Date | 1999-08-18 |
| Summary: | summary |