The following data is part of a premarket notification filed by Zimmar Consulting Ltd. with the FDA for Pharma-plast Suction Set Type Yankauer.
| Device ID | K843468 |
| 510k Number | K843468 |
| Device Name: | PHARMA-PLAST SUCTION SET TYPE YANKAUER |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| Applicant | ZIMMAR CONSULTING LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-11-23 |