The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Roll-a-way Sharps Disposal System (red And Ivory).
| Device ID | K943740 |
| 510k Number | K943740 |
| Device Name: | ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | PREMIUM PLASTICS, INC. 465 W. CERMAK RD. Chicago, IL 60616 |
| Contact | Gary P Garbin |
| Correspondent | Gary P Garbin PREMIUM PLASTICS, INC. 465 W. CERMAK RD. Chicago, IL 60616 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-12-14 |