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 Device, Irrigation, Ocular Surgery
510(k) Number K922996
Device Name MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
Applicant
Chiron Vision Corp.
135 Gibraltar Rd.
Horsham,  PA  19044
Applicant Contact BRUNT MILLER
Correspondent
Chiron Vision Corp.
135 Gibraltar Rd.
Horsham,  PA  19044
Correspondent Contact BRUNT MILLER
Regulation Number886.4360
Classification Product Code
KYG  
Date Received06/22/1992
Decision Date 07/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-