The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Hydrocephalus Valves, Catheters & Accessories (bundled).
Device ID | K172022 |
510k Number | K172022 |
Device Name: | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) |
Classification | Shunt, Central Nervous System And Components |
Applicant | Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
Contact | Christopher Garete |
Correspondent | Christopher Garete Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-05 |
Decision Date | 2017-10-03 |
Summary: | summary |