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 sponge, ophthalmic
510(k) Number K842601
Device Name PRE-OPERATIVE OPHTHALMIC DRESSING TRAY
Applicant
OPHTHALMIC RESOURCES, INC.
928EIGHTEENTH ST. N
ST. PETERSBURG,  FL  33713 -
Applicant Contact JAMES E VOSE
Correspondent
OPHTHALMIC RESOURCES, INC.
928EIGHTEENTH ST. N
ST. PETERSBURG,  FL  33713 -
Correspondent Contact JAMES E VOSE
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received07/05/1984
Decision Date 05/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-