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 K881419
Device Name PLASTIC FRAME & LENS SUNGLASS
Applicant
Marketing Innovations Intl., Inc.
23901 Calabasas Rd.
Suite 1051
Calabasas,  CA  91302
Applicant Contact James Smith
Correspondent
Marketing Innovations Intl., Inc.
23901 Calabasas Rd.
Suite 1051
Calabasas,  CA  91302
Correspondent Contact James Smith
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/04/1988
Decision Date 05/25/1988
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
-
-