The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Hi Volume Pumping Chamber.
Device ID | K802561 |
510k Number | K802561 |
Device Name: | HI VOLUME PUMPING CHAMBER |
Classification | Device, Media Dispensing/stacking |
Applicant | ACACIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTB |
CFR Regulation Number | 866.2440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-16 |
Decision Date | 1980-10-31 |