The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Ksea Instrument Set For Saphenous Vein Harvesting.
| Device ID | K973068 |
| 510k Number | K973068 |
| Device Name: | KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551167939 | K973068 | 000 |