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 Endoscope Holder
510(k) Number K190576
Device Name WalterLorenz Surgical Assist Arm Scope Holder
Applicant
Biomet Microfixation
1520 Tradeport Drive
Jacksonville,  FL  32218
Applicant Contact Lauren Jasper
Correspondent
Biomet Microfixation
1520 Tradeport Drive
Jacksonville,  FL  32218
Correspondent Contact Lauren Jasper
Regulation Number876.1500
Classification Product Code
OCV  
Subsequent Product Code
GCJ  
Date Received03/06/2019
Decision Date 06/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-