The following data is part of a premarket notification filed by Jewett Refrigerator Co., Inc. with the FDA for Refrigerator, Freezer, Blood Storage.
Device ID | BK970028 |
510k Number | BK970028 |
Device Name: | Refrigerator, Freezer, Blood Storage |
Classification | Refrigerator, Freezer, Blood Storage |
Applicant | Jewett Refrigerator Co., Inc. 2-18 Letchworth Street Buffalo, NY 14213 US |
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 | 1997-08-04 |
Decision Date | 1997-10-15 |