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 Otoscope
510(k) Number K904659
Device Name DR. DEDO'S FAMILY EAR EXAMINATION KIT
Applicant
Panex Corp.
631 U.S. Hwy. One
Suite 300
North Palm Beach,  FL  33408
Applicant Contact JAHN, II
Correspondent
Panex Corp.
631 U.S. Hwy. One
Suite 300
North Palm Beach,  FL  33408
Correspondent Contact JAHN, II
Regulation Number874.4770
Classification Product Code
ERA  
Date Received10/15/1990
Decision Date 04/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-