The following data is part of a premarket notification filed by Greiner Bio-one North America, Inc. with the FDA for Safety Infusion Set.
| Device ID | K121908 |
| 510k Number | K121908 |
| Device Name: | SAFETY INFUSION SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Contact | Judith Smith |
| Correspondent | Judith Smith GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942354498 | K121908 | 000 |
| 10889942293933 | K121908 | 000 |
| 10193489435702 | K121908 | 000 |