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 Plug, Punctum
510(k) Number K946357
Device Name COLLAGEN INTRACANALICULAR PLUG
Applicant
Oasis Medical, Inc.
514 S. Vermont Ave.
P.O. Box 1137
Glendora,  CA  91741
Applicant Contact JAMES CHRISTENSEN
Correspondent
Oasis Medical, Inc.
514 S. Vermont Ave.
P.O. Box 1137
Glendora,  CA  91741
Correspondent Contact JAMES CHRISTENSEN
Classification Product Code
LZU  
Date Received12/30/1994
Decision Date 02/07/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-