The following data is part of a premarket notification filed by Sopro - Acteon Group with the FDA for S698 Symbioz Flow.
| Device ID | K153367 |
| 510k Number | K153367 |
| Device Name: | S698 Symbioz Flow |
| Classification | Insufflator, Laparoscopic |
| Applicant | SOPRO - ACTEON GROUP ZAC ATHELIA IV AVENUE DES GENEVRIERS La Ciotat, FR 13705 |
| Contact | Philippe Boyer |
| Correspondent | John R Manthei ACTEON, INC. 555 Eleventh Street, NW Suite 1000 Washington, DC 20004 -1304 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-06-17 |