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 Tube, Tympanostomy
510(k) Number K200952
Device Name Hummingbird Tympanostomy Tube System
Applicant
Preceptis Medical, Inc.
10900 89th Ave. N., Suite 4
Maple Grove,  MN  55369
Applicant Contact Steve Anderson
Correspondent
Preceptis Medical, Inc.
10900 89th Ave. N., Suite 4
Maple Grove,  MN  55369
Correspondent Contact Steve Anderson
Regulation Number874.3880
Classification Product Code
ETD  
Date Received04/09/2020
Decision Date 06/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-