• 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 set, lens, trial, ophthalmic
510(k) Number K934859
Device Name CONTACT LENSES
Applicant
ARNO INTL., INC.
330 S. STATE RD. 7, SUITE B
PLANTATION,  FL  33317
Applicant Contact G. FRANCI
Correspondent
ARNO INTL., INC.
330 S. STATE RD. 7, SUITE B
PLANTATION,  FL  33317
Correspondent Contact G. FRANCI
Regulation Number886.1405
Classification Product Code
HPC  
Date Received10/12/1993
Decision Date 12/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-