The following data is part of a premarket notification filed by Zimmar Consulting Ltd. with the FDA for Pharma-plast Single Use Overshoes.
| Device ID | K843475 |
| 510k Number | K843475 |
| Device Name: | PHARMA-PLAST SINGLE USE OVERSHOES |
| Classification | Cover, Shoe, Operating-room |
| Applicant | ZIMMAR CONSULTING LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-10-31 |