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 K952438
Device Name SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
Applicant
Taiwan Eva Industrial Co., Inc.
P.O. Box 1445
Kaohsiung,  TW
Applicant Contact HOLLY LIN
Correspondent
Taiwan Eva Industrial Co., Inc.
P.O. Box 1445
Kaohsiung,  TW
Correspondent Contact HOLLY LIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/25/1995
Decision Date 09/12/1995
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
-
-