The following data is part of a premarket notification filed by Evergreen Scientific, Inc. with the FDA for Ftk Fecal Transport Kit.
Device ID | K890134 |
510k Number | K890134 |
Device Name: | FTK FECAL TRANSPORT KIT |
Classification | Device, Specimen Collection |
Applicant | EVERGREEN SCIENTIFIC, INC. 2300 EAST 49TH ST. P.O. BOX 58248 Los Angeles, CA 90058 |
Contact | Wong |
Correspondent | Wong EVERGREEN SCIENTIFIC, INC. 2300 EAST 49TH ST. P.O. BOX 58248 Los Angeles, CA 90058 |
Product Code | LIO |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-13 |
Decision Date | 1989-04-21 |