The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Pneumothorax Kit, Modification.
| Device ID | K904021 |
| 510k Number | K904021 |
| Device Name: | PNEUMOTHORAX KIT, MODIFICATION |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| 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 | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902071737 | K904021 | 000 |
| 20801902156239 | K904021 | 000 |
| 10801902004809 | K904021 | 000 |
| 10801902053272 | K904021 | 000 |
| 20801902120148 | K904021 | 000 |
| 20801902120209 | K904021 | 000 |
| 40801902004800 | K904021 | 000 |
| 30801902004803 | K904021 | 000 |
| 30801902053276 | K904021 | 000 |
| 20801902194644 | K904021 | 000 |