The following data is part of a premarket notification filed by Hager Worldwide, Inc. with the FDA for Hager Miramatic Box Sharps Container And Cap Trap Needle Re-capper.
| Device ID | K061933 |
| 510k Number | K061933 |
| Device Name: | HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | HAGER WORLDWIDE, INC. 4 LINCOLN ST Andover, MA 01810 |
| Contact | James Delaney |
| Correspondent | James Delaney HAGER WORLDWIDE, INC. 4 LINCOLN ST Andover, MA 01810 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-07 |
| Decision Date | 2006-11-16 |
| Summary: | summary |