The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Thoracic Surgery Instruments.
| Device ID | K940427 |
| 510k Number | K940427 |
| Device Name: | KARL STORZ THORACIC SURGERY INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini 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 | 1994-01-31 |
| Decision Date | 1994-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551159101 | K940427 | 000 |
| 04048551159095 | K940427 | 000 |
| 04048551048184 | K940427 | 000 |
| 04048551048160 | K940427 | 000 |