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 Ophthalmoscope, Battery-Powered
510(k) Number K093495
Device Name OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
Applicant
American Diagnostic Corp.
55 Commerce Dr.
Hauppauge,  NY  11788
Applicant Contact MICHAEL FALCO
Correspondent
American Diagnostic Corp.
55 Commerce Dr.
Hauppauge,  NY  11788
Correspondent Contact MICHAEL FALCO
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received11/10/2009
Decision Date 11/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-