The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Resp-bac Bacteria Filter.
| Device ID | K851070 |
| 510k Number | K851070 |
| Device Name: | RESP-BAC BACTERIA FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MEDICOMP, INC. 411 FREEMONT ST. Anoka, MN 55303 |
| Contact | Paul England |
| Correspondent | Paul England MEDICOMP, INC. 411 FREEMONT ST. Anoka, MN 55303 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-18 |
| Decision Date | 1985-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858409005365 | K851070 | 000 |
| 10858409005037 | K851070 | 000 |
| 00858409005023 | K851070 | 000 |
| 10858409005013 | K851070 | 000 |
| 00858409005009 | K851070 | 000 |
| 00819989014904 | K851070 | 000 |