The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Icpm Side Ported Needle.
| Device ID | K881858 |
| 510k Number | K881858 |
| Device Name: | ACE ICPM SIDE PORTED NEEDLE |
| Classification | Monitor, Pressure, Intracompartmental |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | LXC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-03 |
| Decision Date | 1988-05-27 |