The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for P-s Surgical Drain.
| Device ID | K801442 |
| 510k Number | K801442 |
| Device Name: | P-S SURGICAL DRAIN |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 |