The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Pneumothorax Kit, Ak-01500.
| Device ID | K883905 |
| 510k Number | K883905 |
| Device Name: | ARROW PNEUMOTHORAX KIT, AK-01500 |
| Classification | Catheter And Tip, Suction |
| 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 | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-15 |
| Decision Date | 1989-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902097898 | K883905 | 000 |
| 30801902004162 | K883905 | 000 |
| 20801902209102 | K883905 | 000 |
| 20801902193999 | K883905 | 000 |