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 K933323
Device Name RUSSELL & HANCOCK 524 AND 422 SUNGLASSES
Applicant
Russell & Hancock, Ltd.
11 Attercliffe Rd.
Chorlton-Cum-Hardy,
Manchester M211fs,  GB
Applicant Contact MHA RUSSELL
Correspondent
Russell & Hancock, Ltd.
11 Attercliffe Rd.
Chorlton-Cum-Hardy,
Manchester M211fs,  GB
Correspondent Contact MHA RUSSELL
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/07/1993
Decision Date 12/21/1993
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
-
-