The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Hydro-bac Filter.
| Device ID | K852866 |
| 510k Number | K852866 |
| Device Name: | HYDRO-BAC FILTER |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | MEDICOMP, INC. 5225 LAKELAND AVE. NORTH Mpls, MN 55429 |
| Contact | Duncan G Johnson |
| Correspondent | Duncan G Johnson MEDICOMP, INC. 5225 LAKELAND AVE. NORTH Mpls, MN 55429 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-08 |
| Decision Date | 1986-01-01 |