The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Endoscopes, Telescope Holders.
| Device ID | K951535 |
| 510k Number | K951535 |
| Device Name: | KARL STORZ ENDOSCOPES, TELESCOPE HOLDERS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551405116 | K951535 | 000 |
| 04048551111048 | K951535 | 000 |
| 04048551111055 | K951535 | 000 |
| 04048551111383 | K951535 | 000 |
| 04048551111413 | K951535 | 000 |
| 04048551265222 | K951535 | 000 |
| 04048551265239 | K951535 | 000 |
| 04048551313114 | K951535 | 000 |
| 04048551321560 | K951535 | 000 |
| 04048551322475 | K951535 | 000 |
| 04048551322482 | K951535 | 000 |
| 04048551337400 | K951535 | 000 |
| 04048551366967 | K951535 | 000 |
| 04048551111031 | K951535 | 000 |