The following data is part of a premarket notification filed by Pro-tec Containers, Inc. with the FDA for Pro-tec Disposable Sharps Containers Ir180 & Ir80.
| Device ID | K945274 |
| 510k Number | K945274 |
| Device Name: | PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | PRO-TEC CONTAINERS, INC. 108 COMMERCE ST. STE 105 Lake Mary, FL 32746 |
| Contact | Treesa Spencer |
| Correspondent | Treesa Spencer PRO-TEC CONTAINERS, INC. 108 COMMERCE ST. STE 105 Lake Mary, FL 32746 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1994-12-14 |