The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Large Joint Arthroscopy Set.
| Device ID | K963524 |
| 510k Number | K963524 |
| Device Name: | KSEA LARGE JOINT ARTHROSCOPY SET |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-04 |
| Decision Date | 1996-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551095140 | K963524 | 000 |
| 04048551020609 | K963524 | 000 |