The following data is part of a premarket notification filed by Pacific Device, Inc. with the FDA for Transfer Set.
Device ID | K923782 |
510k Number | K923782 |
Device Name: | TRANSFER SET |
Classification | Set, I.v. Fluid Transfer |
Applicant | PACIFIC DEVICE, INC. 8572 SPECTRUM LN. San Diego, CA 92121 |
Contact | Jim Caputo |
Correspondent | Jim Caputo 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 | 1992-07-28 |
Decision Date | 1993-07-02 |