The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Vaku-8 Blood Collection Needles.
| Device ID | K090426 |
| 510k Number | K090426 |
| Device Name: | VAKU-8 BLOOD COLLECTION NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MYCO MEDICAL SUPPLIES, INC. 158 TOWERVIEW COURT Cary, NC 27513 |
| Contact | Sanjiv Kumar |
| Correspondent | Sanjiv Kumar MYCO MEDICAL SUPPLIES, INC. 158 TOWERVIEW COURT Cary, NC 27513 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-19 |
| Decision Date | 2009-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20386120008022 | K090426 | 000 |
| 20386120008015 | K090426 | 000 |
| 20386120008008 | K090426 | 000 |
| 20386120007995 | K090426 | 000 |
| 20386120007988 | K090426 | 000 |
| 20386120007971 | K090426 | 000 |
| 20386120007964 | K090426 | 000 |
| 20386120007957 | K090426 | 000 |
| 20386120007940 | K090426 | 000 |