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 |