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 Screen, Tangent, Target
510(k) Number K844657
Device Name SPECTABLE FRAME MAGNIFYING BRILLETTE
Applicant
Pro Design Intl. AS
20 Waterside Plz.
Apt. 31-D
New York,  NY  10010
Applicant Contact LARS KLITBO
Correspondent
Pro Design Intl. AS
20 Waterside Plz.
Apt. 31-D
New York,  NY  10010
Correspondent Contact LARS KLITBO
Regulation Number886.1810
Classification Product Code
HOJ  
Date Received11/29/1984
Decision Date 12/11/1984
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
-
-