The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Unipor Breathing Circuit Filter.
| Device ID | K791307 |
| 510k Number | K791307 |
| Device Name: | UNIPOR BREATHING CIRCUIT FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-16 |
| Decision Date | 1979-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30636207300691 | K791307 | 000 |
| 30636207300684 | K791307 | 000 |
| 30636207000744 | K791307 | 000 |
| 30363207000244 | K791307 | 000 |
| 30636207000232 | K791307 | 000 |
| 00636207000248 | K791307 | 000 |