The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Ambu Pump Spik Tub Set Pacret Provid Pump Set.
| Device ID | K925058 |
| 510k Number | K925058 |
| Device Name: | BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET |
| Classification | Set, Administration, Intravascular |
| Applicant | C.R. BARD, INC. 87 CONCORD RD. North Reading, MA 01864 |
| Contact | Bruce W Husel |
| Correspondent | Bruce W Husel C.R. BARD, INC. 87 CONCORD RD. North Reading, MA 01864 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-06 |
| Decision Date | 1993-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412004117 | K925058 | 000 |