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 illuminator, fiberoptic, surgical field
510(k) Number K921866
Device Name LUMINOUS 250 FIBEROPTIC ILLUMINATOR
Applicant
PROGRESSIVE DYNAMICS, INC.
507 INDUSTRIAL RD.
MARSHALL,  MI  49068 -1796
Applicant Contact WILLIAM F LOHNESS
Correspondent
PROGRESSIVE DYNAMICS, INC.
507 INDUSTRIAL RD.
MARSHALL,  MI  49068 -1796
Correspondent Contact WILLIAM F LOHNESS
Regulation Number878.4580
Classification Product Code
HBI  
Date Received04/20/1992
Decision Date 07/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-