The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Saphenous Vein Harvest Scope.
| Device ID | K964930 |
| 510k Number | K964930 |
| Device Name: | STRYKER SAPHENOUS VEIN HARVEST SCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Bob Dahla |
| Correspondent | Bob Dahla Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-09 |
| Decision Date | 1997-02-28 |
| Summary: | summary |