• 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 keratome, battery-powered
510(k) Number K902857
Device Name VISI-DRAPE OPHTHALMIC DRAPES
Applicant
VISITEC CO.
7575 COMMERCE COURT
SARASOTA,  FL  34243 -3218
Applicant Contact LIAQUAT ALLARAKHIA
Correspondent
VISITEC CO.
7575 COMMERCE COURT
SARASOTA,  FL  34243 -3218
Correspondent Contact LIAQUAT ALLARAKHIA
Regulation Number886.4370
Classification Product Code
HMY  
Date Received06/29/1990
Decision Date 07/31/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-