The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Unolok Plus Infusion Set And Vaku-8 Plus Blood Collection Set.
| Device ID | K000592 |
| 510k Number | K000592 |
| Device Name: | UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MYCO MEDICAL SUPPLIES, INC. 101 ROSE VALLEY WOODS DR. Cary, NC 27513 |
| Contact | Sanjiv Kumar |
| Correspondent | Sanjiv Kumar MYCO MEDICAL SUPPLIES, INC. 101 ROSE VALLEY WOODS DR. Cary, NC 27513 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2001-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18903347023475 | K000592 | 000 |
| 08903347002343 | K000592 | 000 |
| 08903347002350 | K000592 | 000 |
| 08903347002367 | K000592 | 000 |
| 08903347023423 | K000592 | 000 |
| 08903347023430 | K000592 | 000 |
| 08903347023447 | K000592 | 000 |
| 08903347023454 | K000592 | 000 |
| 18903347023468 | K000592 | 000 |
| 08903347002336 | K000592 | 000 |