The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for P-s Suction Reservoir.
| Device ID | K801443 |
| 510k Number | K801443 |
| Device Name: | P-S SUCTION RESERVOIR |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-20 |
| Decision Date | 1980-07-14 |