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 instrument, vitreous aspiration and cutting, ac-powered
510(k) Number K853308
Device Name KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000
Applicant
FRIGITRONICS OF CONNECTICUT, INC.
770 RIVER RD.
P.O. BOX 855
SHELTON,  CT  06484
Applicant Contact CLIFF F POTOCKY
Correspondent
FRIGITRONICS OF CONNECTICUT, INC.
770 RIVER RD.
P.O. BOX 855
SHELTON,  CT  06484
Correspondent Contact CLIFF F POTOCKY
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/07/1985
Decision Date 10/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-