The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ipi Import.
| Device ID | K922419 |
| 510k Number | K922419 |
| Device Name: | IPI IMPORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 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 | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1992-11-20 |