The following data is part of a premarket notification filed by Sigma Intl. with the FDA for Sigma Syringe Delivery System(multi-doser Rev. 1/multi-doser Rev. Ii/single-doser Rev. 1-10/single-doser Rev. 1-20/.
| Device ID | K962709 |
| 510k Number | K962709 |
| Device Name: | SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/ |
| Classification | Pump, Infusion |
| Applicant | SIGMA INTL. 711 PARK AVE. Medina, NY 14103 -0756 |
| Contact | Patrick W Penque |
| Correspondent | Patrick W Penque SIGMA INTL. 711 PARK AVE. Medina, NY 14103 -0756 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-12 |
| Decision Date | 1996-10-07 |
| Summary: | summary |