The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Filter, Infusion Blood (1 Pff-100).
Device ID | K760165 |
510k Number | K760165 |
Device Name: | FILTER, INFUSION BLOOD (1 PFF-100) |
Classification | Microfilter, Blood Transfusion |
Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-06 |
Decision Date | 1976-08-06 |