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 | K792005 |
510k Number | K792005 |
Device Name: | CSF-CARDIAC/PERITONEAL CATHETER |
Classification | Shunt, Central Nervous System And Components |
Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-05 |
Decision Date | 1980-01-16 |