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 Frame, Spectacle
510(k) Number K943084
Device Name SPECTACLE FRAME
Applicant
Samil Enterprise Co.
120 E. Baltimore St.
Baltimore,  MD  21202
Applicant Contact PEGGY CHAPLIN
Correspondent
Samil Enterprise Co.
120 E. Baltimore St.
Baltimore,  MD  21202
Correspondent Contact PEGGY CHAPLIN
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received06/28/1994
Decision Date 07/25/1994
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
-
-