The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Synergetics Adjustable Gas Pressurized Infusion (agpi) Tube Set.
| Device ID | K091441 |
| 510k Number | K091441 |
| Device Name: | SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET |
| Classification | Pump, Infusion |
| Applicant | SYNERGETICS, INC. 3845 CORPORATE CENTRE DR. O'fallon, MO 63368 |
| Contact | Gary Oliveros |
| Correspondent | Gary Oliveros SYNERGETICS, INC. 3845 CORPORATE CENTRE DR. O'fallon, MO 63368 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-15 |
| Decision Date | 2009-10-30 |
| Summary: | summary |