The following data is part of a premarket notification filed by Surgidev Corp. with the FDA for Acuflo Volumetric Controlled Delivery Sys 2000.
| Device ID | K850729 |
| 510k Number | K850729 |
| Device Name: | ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000 |
| Classification | Pump, Infusion |
| Applicant | SURGIDEV CORP. 5743 THORNWOOD DR. Goleta, CA 93117 |
| Contact | Michael E Pfleger |
| Correspondent | Michael E Pfleger SURGIDEV CORP. 5743 THORNWOOD DR. Goleta, CA 93117 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-22 |
| Decision Date | 1985-04-09 |