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 Spectacle, Magnifying
510(k) Number K943613
Device Name NIL
Applicant
Sing Wah International Enterprises , Ltd.
4010-4018 Jardine House,
1 Connaught Pl. Centre
Connaught,  HK
Applicant Contact WESLEY TSE
Correspondent
Sing Wah International Enterprises , Ltd.
4010-4018 Jardine House,
1 Connaught Pl. Centre
Connaught,  HK
Correspondent Contact WESLEY TSE
Regulation Number886.5840
Classification Product Code
HOI  
Date Received07/27/1994
Decision Date 09/21/1994
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
-
-