Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K193499
Device Name DigiGuide System
Applicant
Protomed, Inc.
1329 W 121st Ave.
Westminster,  CO  80234
Applicant Contact James Jimenez
Correspondent
Protomed, Inc.
1329 W 121st Ave.
Westminster,  CO  80234
Correspondent Contact Rick Miller
Regulation Number872.4120
Classification Product Code
DZJ  
Subsequent Product Code
LLZ  
Date Received12/17/2019
Decision Date 11/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-