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 unit, phacofragmentation
510(k) Number K902876
Device Name PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI.
Applicant
INTRAOPTICS SURGICAL, INC.
15500-A ROCKFIELD
IRVINE,  CA  92718
Applicant Contact DAN BROSTOFF
Correspondent
INTRAOPTICS SURGICAL, INC.
15500-A ROCKFIELD
IRVINE,  CA  92718
Correspondent Contact DAN BROSTOFF
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/02/1990
Decision Date 09/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-