The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Cat. #9972 Refrigeration Medium (test Yolk Buffer).
Device ID | K872203 |
510k Number | K872203 |
Device Name: | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) |
Classification | Cap, Cervical |
Applicant | IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
Contact | Paul S Weathersbee |
Correspondent | Paul S Weathersbee IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
Product Code | HDR |
CFR Regulation Number | 884.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-08 |
Decision Date | 1987-08-14 |