The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Continuous Epidural Anesthesia Kit W/poly Catheter.
| Device ID | K884552 |
| 510k Number | K884552 |
| Device Name: | CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER |
| Classification | Anesthesia Conduction Kit |
| Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-31 |
| Decision Date | 1989-03-14 |