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 Light, Surgical, Ceiling Mounted
510(k) Number K131893
Device Name AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
Applicant
AJW TECHNOLOGY CONSULTANTS, INC.
445 APOLLO BEACH BLVD
APOLLO BEACH,  FL  33572
Applicant Contact JANET DOUGLAS
Correspondent
AJW TECHNOLOGY CONSULTANTS, INC.
445 APOLLO BEACH BLVD
APOLLO BEACH,  FL  33572
Correspondent Contact JANET DOUGLAS
Regulation Number878.4580
Classification Product Code
FSY  
Date Received06/25/2013
Decision Date 10/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-