The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Needleless Injection Cannula.
| Device ID | K923653 |
| 510k Number | K923653 |
| Device Name: | NEEDLELESS INJECTION CANNULA |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ARROW INTL., INC. P.O. BOX 12888 3000 BERNVILLE RD Reading, PA 19612 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. P.O. BOX 12888 3000 BERNVILLE RD Reading, PA 19612 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1993-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902003653 | K923653 | 000 |
| 30801902003646 | K923653 | 000 |