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 K962767
Device Name MS401097-17,MS722-K,MS720,MS721,MS722
Applicant
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Applicant Contact JON GAMERDINGER
Correspondent
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Correspondent Contact JON GAMERDINGER
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received07/16/1996
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-