The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Single Step Medium.
Device ID | K072609 |
510k Number | K072609 |
Device Name: | SINGLE STEP MEDIUM |
Classification | Media, Reproductive |
Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST Santa Ana, CA 92705 |
Contact | Wendell Lee |
Correspondent | Wendell Lee IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST Santa Ana, CA 92705 |
Product Code | MQL |
CFR Regulation Number | 884.6180 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2007-09-17 |
Decision Date | 2008-02-12 |
Summary: | summary |