The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Olympus Subfascial Endoscopic Perforating Vein Surgery (seps) System, Its Associated Accessories And Ancillary Equipment.
| Device ID | K973232 |
| 510k Number | K973232 |
| Device Name: | OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS WINTER & IBE GMBH KUEHNSTRASSE 61 Hamburg 70, DE 2000 |
| Contact | Subhash R Patel |
| Correspondent | Subhash R Patel OLYMPUS WINTER & IBE GMBH KUEHNSTRASSE 61 Hamburg 70, DE 2000 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-28 |
| Decision Date | 1997-11-21 |
| Summary: | summary |