The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Integral Drainage/ventricular/lumbar Drainage Sets.
Device ID | K924600 |
510k Number | K924600 |
Device Name: | INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS |
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 | 1992-09-11 |
Decision Date | 1992-12-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10381780034209 | K924600 | 000 |
10381780034193 | K924600 | 000 |
30381780034180 | K924600 | 000 |
30381780034173 | K924600 | 000 |