The following data is part of a premarket notification filed by Medcad with the FDA for Medcad® Accuplan® System.
Device ID | K192282 |
510k Number | K192282 |
Device Name: | MedCAD® AccuPlan® System |
Classification | Driver, Wire, And Bone Drill, Manual |
Applicant | MedCAD 501 2nd Ave, Suite A-1000 Dallas, TX 75226 |
Contact | Brian Buss |
Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
Product Code | DZJ |
CFR Regulation Number | 872.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-22 |
Decision Date | 2020-10-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810007630533 | K192282 | 000 |
00810007630281 | K192282 | 000 |
00810007630274 | K192282 | 000 |
00810007630267 | K192282 | 000 |
00810007630250 | K192282 | 000 |
00810007630243 | K192282 | 000 |
00810007630236 | K192282 | 000 |
00810007630229 | K192282 | 000 |
00810007630212 | K192282 | 000 |
00810007630205 | K192282 | 000 |
00810007630298 | K192282 | 000 |
00810007630304 | K192282 | 000 |
00810007630441 | K192282 | 000 |
00810007630427 | K192282 | 000 |
00810007630373 | K192282 | 000 |
00810007630366 | K192282 | 000 |
00810007630359 | K192282 | 000 |
00810007630342 | K192282 | 000 |
00810007630335 | K192282 | 000 |
00810007630328 | K192282 | 000 |
00810007630311 | K192282 | 000 |
00810007630199 | K192282 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MEDCAD 87827361 5687821 Live/Registered |
Vanduzen, Inc 2018-03-09 |
MEDCAD 78841748 3332287 Dead/Cancelled |
VanDuzen, Inc. 2006-03-20 |