The following data is part of a premarket notification filed by American V. Mueller with the FDA for Heyer-schulte Hermetic External Csf Drain. System.
Device ID | K864676 |
510k Number | K864676 |
Device Name: | HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM |
Classification | Shunt, Central Nervous System And Components |
Applicant | AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
Contact | Matthew Nowland |
Correspondent | Matthew Nowland AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-02 |
Decision Date | 1986-12-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10381780072386 | K864676 | 000 |
30381780071659 | K864676 | 000 |
10381780023937 | K864676 | 000 |
10381780542209 | K864676 | 000 |