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 Laparoscope, General & Plastic Surgery
510(k) Number K231622
Device Name REGER Nebulizer Irrigation Cannula
Applicant
REGER Medizintechnik, GmbH
Gewerbestrasse 10
Villingendorf,  DE 78667
Applicant Contact Christopher Kohn
Correspondent
QSR Consulting
10807 Dakota Ranch Rd.
Santee,  CA  92071
Correspondent Contact Kenneth Kleinhenz
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/02/2023
Decision Date 09/29/2023
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
-
-