The following data is part of a premarket notification filed by Allen Medical Systems, Inc. with the FDA for High Volume I.v. & Irrigation Tower.
| Device ID | K960027 |
| 510k Number | K960027 |
| Device Name: | HIGH VOLUME I.V. & IRRIGATION TOWER |
| Classification | Stand, Infusion |
| Applicant | ALLEN MEDICAL SYSTEMS, INC. 5198 RICHMOND RD. Bedford Heights, OH 44146 |
| Contact | Suzanne K Ratzloff |
| Correspondent | Suzanne K Ratzloff ALLEN MEDICAL SYSTEMS, INC. 5198 RICHMOND RD. Bedford Heights, OH 44146 |
| Product Code | FOX |
| CFR Regulation Number | 880.6990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-03-12 |