The following data is part of a premarket notification filed by Nor-lake, Inc. with the FDA for Refrigerator, Freezer, Blood Storage.
Device ID | BK930003 |
510k Number | BK930003 |
Device Name: | Refrigerator, Freezer, Blood Storage |
Classification | Refrigerator, Freezer, Blood Storage |
Applicant | Nor-Lake, Inc. second And Elm Str. P.o. Box 248 Hudson, WI 54016 |
Product Code | KSE |
CFR Regulation Number | 864.9700 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-04 |
Decision Date | 1995-04-13 |