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 |