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 K935541
Device Name SUNGLASSES
Applicant
SEVEN PYRAMID ENT CO., LTD.
OFFICE #4, ALLEY 14, LANE 333
HSIN-MING ROAD
TAIPEI 11413, TAIWAN, R.O.C.,  TW
Applicant Contact SAM HO
Correspondent
SEVEN PYRAMID ENT CO., LTD.
OFFICE #4, ALLEY 14, LANE 333
HSIN-MING ROAD
TAIPEI 11413, TAIWAN, R.O.C.,  TW
Correspondent Contact SAM HO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/16/1993
Decision Date 01/06/1994
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
-
-