The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Gravity Compensating Accessory.
Device ID | K932429 |
510k Number | K932429 |
Device Name: | CORDIS GRAVITY COMPENSATING ACCESSORY |
Classification | Shunt, Central Nervous System And Components |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Marvin L Sussman |
Correspondent | Marvin L Sussman CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-20 |
Decision Date | 1994-07-20 |