• 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 K921607
Device Name IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE
Applicant
CHIRON VISION CORP.
135 GIBRALTAR RD.
HORSHAM,  PA  19044
Applicant Contact JAMES K MCCRACKEN
Correspondent
CHIRON VISION CORP.
135 GIBRALTAR RD.
HORSHAM,  PA  19044
Correspondent Contact JAMES K MCCRACKEN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received04/03/1992
Decision Date 06/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-