The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Pca Ii Infusion Pump.
Device ID | K880733 |
510k Number | K880733 |
Device Name: | BARD PCA II INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | C.R. BARD, INC. 87 CONCORD RD. North Reading, MA 01864 |
Contact | Eric P Ankerud |
Correspondent | Eric P Ankerud C.R. BARD, INC. 87 CONCORD RD. North Reading, MA 01864 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-24 |
Decision Date | 1988-06-20 |