The following data is part of a premarket notification filed by Cardinal Health, Alaris Products with the FDA for Alaris Safety Male Luer.
| Device ID | K053049 |
| 510k Number | K053049 |
| Device Name: | ALARIS SAFETY MALE LUER |
| Classification | Set, Administration, Intravascular |
| Applicant | CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
| Contact | Stacy L Lewis |
| Correspondent | Stacy L Lewis CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-28 |
| Decision Date | 2006-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403221703 | K053049 | 000 |
| 30849884000017 | K053049 | 000 |