The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Miniature Telescope And Accessories.
| Device ID | K010987 |
| 510k Number | K010987 |
| Device Name: | KSEA MINIATURE TELESCOPE AND ACCESSORIES |
| Classification | Arthroscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | James A Lee |
| Correspondent | James A Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 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 | 2001-04-02 |
| Decision Date | 2001-06-19 |