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 Syringe, Irrigating (Non Dental)
510(k) Number K903759
Device Name IRRICLEAR EAR IRRIGATION SYRINGE
Applicant
Nortech Laboratories, Inc.
1205 Arrowhead Dr.
Dubuque,  IA  52001
Applicant Contact MICHAEL ZEMAN
Correspondent
Nortech Laboratories, Inc.
1205 Arrowhead Dr.
Dubuque,  IA  52001
Correspondent Contact MICHAEL ZEMAN
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received08/20/1990
Decision Date 10/26/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-