The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Csf-cardiac/peritoneal Catheter.
| Device ID | K871752 |
| 510k Number | K871752 |
| Device Name: | CSF-CARDIAC/PERITONEAL CATHETER |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Contact | Stephen W Laguette |
| Correspondent | Stephen W Laguette PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-08 |
| Decision Date | 1987-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994908629 | K871752 | 000 |
| 00643169010635 | K871752 | 000 |
| 00643169010376 | K871752 | 000 |
| 00643169507531 | K871752 | 000 |
| 00643169497368 | K871752 | 000 |
| 00643169483309 | K871752 | 000 |
| 00643169483293 | K871752 | 000 |
| 00673978249117 | K871752 | 000 |