The following data is part of a premarket notification filed by Pacific Device, Inc. with the FDA for Vitalmix (set & Bag).
Device ID | K902482 |
510k Number | K902482 |
Device Name: | VITALMIX (SET & BAG) |
Classification | Set, I.v. Fluid Transfer |
Applicant | PACIFIC DEVICE, INC. 8572 SPECTRUM LN. San Diego, CA 92121 |
Contact | Mike Shannon |
Correspondent | Mike Shannon PACIFIC DEVICE, INC. 8572 SPECTRUM LN. San Diego, CA 92121 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-04 |
Decision Date | 1990-07-02 |