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 Pump, Infusion, Ophthalmic
510(k) Number K974253
Device Name CPD COMMANDER
Applicant
Scieran Technologies, Inc.
27071 Cabot Rd., Suite 127
Laguna Hills,  CA  92653
Applicant Contact ROD ROSS
Correspondent
Scieran Technologies, Inc.
27071 Cabot Rd., Suite 127
Laguna Hills,  CA  92653
Correspondent Contact ROD ROSS
Regulation Number880.5725
Classification Product Code
MRH  
Subsequent Product Code
FRN  
Date Received11/13/1997
Decision Date 02/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-