The following data is part of a premarket notification filed by Conception Technologies with the FDA for Oil For Tissue Culture.
Device ID | K011462 |
510k Number | K011462 |
Device Name: | OIL FOR TISSUE CULTURE |
Classification | Media, Reproductive |
Applicant | CONCEPTION TECHNOLOGIES 3722 AVE. SAUSALITO Irvine, CA 92606 |
Contact | Grace Holland |
Correspondent | Grace Holland CONCEPTION TECHNOLOGIES 3722 AVE. SAUSALITO Irvine, CA 92606 |
Product Code | MQL |
CFR Regulation Number | 884.6180 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-14 |
Decision Date | 2001-06-13 |