The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Calcusplit.
| Device ID | K981233 |
| 510k Number | K981233 |
| Device Name: | KSEA CALCUSPLIT |
| Classification | Lithotriptor, Electro-hydraulic |
| 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 | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-03 |
| Decision Date | 1998-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551086322 | K981233 | 000 |
| 04048551086551 | K981233 | 000 |
| 04048551086599 | K981233 | 000 |
| 04048551086643 | K981233 | 000 |
| 04048551086667 | K981233 | 000 |
| 04048551086698 | K981233 | 000 |
| 04048551086773 | K981233 | 000 |
| 04048551086797 | K981233 | 000 |
| 04048551086810 | K981233 | 000 |
| 04048551086834 | K981233 | 000 |
| 04048551086858 | K981233 | 000 |
| 04048551086872 | K981233 | 000 |
| 04048551086896 | K981233 | 000 |
| 04048551086308 | K981233 | 000 |