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 Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K970315
Device Name EVEREST SUNGLASSES
Applicant
Ycc International Corp.
1330 Ponderosa Dr.
Moscow,  ID  83843
Applicant Contact LIHUA WANG
Correspondent
Ycc International Corp.
1330 Ponderosa Dr.
Moscow,  ID  83843
Correspondent Contact LIHUA WANG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/27/1997
Decision Date 05/06/1997
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
-
-