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 shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
510(k) Number K925564
Device Name ACTION MEDTEK/DENTEK EYEGLASSES
Applicant
ACTION EYEWEAR CORP.
1401 DUFF DRIVE, UNIT 100
FORT COLLIN,  CO  80524
Correspondent
ACTION EYEWEAR CORP.
1401 DUFF DRIVE, UNIT 100
FORT COLLIN,  CO  80524
Regulation Number886.4750
Classification Product Code
HOY  
Date Received11/03/1992
Decision Date 10/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-