The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Acrodisc Filter Assembly.
| Device ID | K802765 |
| 510k Number | K802765 |
| Device Name: | ACRODISC FILTER ASSEMBLY |
| Classification | Filter, Infusion Line |
| Applicant | GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-04 |
| Decision Date | 1981-01-21 |