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 Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K162636
Device Name Marco Ultra M3, Marco Ultra M4
Applicant
Takagi Seiko Co., Ltd.
330-2 Iwahune, Nakano-Shi, Nagano-Ken
Nakano,  JP 383-8585
Applicant Contact HAGIWARA TORU
Correspondent
Takagi Seiko Co., Ltd.
330-2 Iwahune, Nakano-Shi, Nagano-Ken
Nakano,  JP 383-8585
Correspondent Contact HAGIWARA TORU
Regulation Number886.1850
Classification Product Code
HJO  
Date Received09/21/2016
Decision Date 04/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-