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 Led Light Source
510(k) Number K091829
Device Name PLS PORTABLE LIGHT SOURCE
Applicant
Optim, Inc.
64 Technology Park Rd.
Sturbridge,  MA  01566
Applicant Contact ROBERT KRUPA
Correspondent
Optim, Inc.
64 Technology Park Rd.
Sturbridge,  MA  01566
Correspondent Contact ROBERT KRUPA
Regulation Number876.1500
Classification Product Code
NTN  
Date Received06/19/2009
Decision Date 07/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-