The following data is part of a premarket notification filed by Sopro with the FDA for S-57 Video Imaging System.
| Device ID | K973794 |
| 510k Number | K973794 |
| Device Name: | S-57 VIDEO IMAGING SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille, FR 13011 |
| Contact | Pierre Montillot |
| Correspondent | Pierre Montillot SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille, FR 13011 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-06 |
| Decision Date | 1998-01-02 |
| Summary: | summary |