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 Implant, Eye Valve
510(k) Number K230975
Device Name Ahmed® Glaucoma Valve Model FP7
Applicant
New World Medical, Inc.
19763 Edison Court
Rancho Cucamonga,  CA  91730
Applicant Contact Victor Arellano
Correspondent
New World Medical, Inc.
19763 Edison Court
Rancho Cucamonga,  CA  91730
Correspondent Contact Victor Arellano
Regulation Number886.3920
Classification Product Code
KYF  
Date Received04/05/2023
Decision Date 05/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-