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 Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K030572
Device Name HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
Applicant
Henke Sass Wolf of America, Inc.
203 Main St.
Pmb 166
Flemington,  NJ  08822
Applicant Contact LYNETTE HOWARD
Correspondent
Henke Sass Wolf of America, Inc.
203 Main St.
Pmb 166
Flemington,  NJ  08822
Correspondent Contact LYNETTE HOWARD
Regulation Number874.4760
Classification Product Code
EOB  
Date Received02/24/2003
Decision Date 04/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-