The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ps Medical Catheter Placement Kit.
| Device ID | K940096 |
| 510k Number | K940096 |
| Device Name: | PS MEDICAL CATHETER PLACEMENT KIT |
| Classification | Endoscope, Neurological |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIVERSITY BUSINESS CENTER 125-B CREMONA DRIVE Goleta, CA 93117 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIVERSITY BUSINESS CENTER 125-B CREMONA DRIVE Goleta, CA 93117 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-07 |
| Decision Date | 1994-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994908483 | K940096 | 000 |
| 00613994908476 | K940096 | 000 |
| 00643169498075 | K940096 | 000 |
| 00681490526852 | K940096 | 000 |