The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Reli Safety Blood Collection Tube Holder, Reli Blood Collection Tube Holder.
| Device ID | K173279 |
| 510k Number | K173279 |
| Device Name: | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MYCO Medical Supplies, Inc. 2015 Production Drive Apex, NC 27539 |
| Contact | Sanjiv Kumar |
| Correspondent | E. J. Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-13 |
| Decision Date | 2018-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20386120009203 | K173279 | 000 |
| 20386120007414 | K173279 | 000 |
| 20386120011275 | K173279 | 000 |