The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Ultipor Vacuum Line Bacteria Fitler.
| Device ID | K812505 |
| 510k Number | K812505 |
| Device Name: | PALL ULTIPOR VACUUM LINE BACTERIA FITLER |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-01 |
| Decision Date | 1981-09-16 |