The following data is part of a premarket notification filed by Sopro with the FDA for Sopro 61d.
| Device ID | K031593 |
| 510k Number | K031593 |
| Device Name: | SOPRO 61D |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille, FR F-13011 |
| Contact | Pierre Montillot |
| Correspondent | Pierre Montillot SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille, FR F-13011 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-21 |
| Decision Date | 2003-09-16 |
| Summary: | summary |