• 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 Pump, Infusion, Ophthalmic
510(k) Number K211680
Device Name Streamline Surgical System
Applicant
New World Medical, Inc.
10763 Edison Court
Rancho Cucamonga,  CA  91730
Applicant Contact Victor Arellano
Correspondent
New World Medical, Inc.
10763 Edison Court
Rancho Cucamonga,  CA  91730
Correspondent Contact Victor Arellano
Regulation Number880.5725
Classification Product Code
MRH  
Subsequent Product Code
HMX  
Date Received06/01/2021
Decision Date 10/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-