The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Dispos. Scott Cannulas 16-1054 Etc..
Device ID | K834477 |
510k Number | K834477 |
Device Name: | DISPOS. SCOTT CANNULAS 16-1054 ETC. |
Classification | Catheter, Ventricular |
Applicant | Codman & Shurtleff, Inc. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HCA |
CFR Regulation Number | 882.4100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-20 |
Decision Date | 1984-03-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20886704000492 | K834477 | 000 |
20886704000485 | K834477 | 000 |
00381780511550 | K834477 | 000 |
00381780511543 | K834477 | 000 |