The following data is part of a premarket notification filed by Greiner Bio-one Na Inc. with the FDA for Greiner Holdex.
| Device ID | K160532 |
| 510k Number | K160532 |
| Device Name: | Greiner Holdex |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GREINER BIO-ONE NA INC. 4238 CAPITAL DRIVE Monroe, NC 28110 |
| Contact | Manfred Abel |
| Correspondent | Manfred Abel GREINER BIO-ONE NA INC. 4238 CAPITAL DRIVE Monroe, NC 28110 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-26 |
| Decision Date | 2016-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120049200239 | K160532 | 000 |