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 |