The following data is part of a premarket notification filed by Bipore, Inc. with the FDA for O.2 Micron Infection Resistant Hydrophobic Filter.
| Device ID | K862015 |
| 510k Number | K862015 |
| Device Name: | O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER |
| Classification | Protector, Transducer, Dialysis |
| Applicant | BIPORE, INC. 16 EDWARD ST. Demarest, NJ 07627 |
| Contact | Elizabeth Koch |
| Correspondent | Elizabeth Koch BIPORE, INC. 16 EDWARD ST. Demarest, NJ 07627 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-07-22 |