The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ps Medical Disposable Subcutaneous Cath Passer.
| Device ID | K930606 |
| 510k Number | K930606 |
| Device Name: | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER |
| Classification | Instrument, Shunt System Implantation |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 125-B CREMONA DR. Goleta, CA 93117 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 125-B CREMONA DR. Goleta, CA 93117 |
| Product Code | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-05 |
| Decision Date | 1993-09-10 |