The following data is part of a premarket notification filed by Bipore, Inc. with the FDA for Bipore O.2 Micron Hydrophobic Filter Assembly.
| Device ID | K844625 |
| 510k Number | K844625 |
| Device Name: | BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| 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 | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-27 |
| Decision Date | 1985-01-16 |