The following data is part of a premarket notification filed by Whatman, Inc. with the FDA for Neocare 20 Micron Blood Filter.
Device ID | K000719 |
510k Number | K000719 |
Device Name: | NEOCARE 20 MICRON BLOOD FILTER |
Classification | Microfilter, Blood Transfusion |
Applicant | WHATMAN, INC. 401 WEST MORGAN RD. Ann Arbor, MI 48108 -9109 |
Contact | Randall D Bath |
Correspondent | Randall D Bath WHATMAN, INC. 401 WEST MORGAN RD. Ann Arbor, MI 48108 -9109 |
Product Code | CAK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-03 |
Decision Date | 2000-05-30 |