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 Implant, Eye Valve
510(k) Number K885125
Device Name KRUPIN EYE VALVE W/SCLERAL BUCKLE
Applicant
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Applicant Contact LEWIS H MARTEN
Correspondent
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Correspondent Contact LEWIS H MARTEN
Regulation Number886.3920
Classification Product Code
KYF  
Date Received12/12/1988
Decision Date 01/24/1989
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
-
-