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 Dressing, Wound, Drug
510(k) Number K153138
Device Name Cerdak Basic
Applicant
Bu Polysciences Equipment & Trading, LLC
10855 Symphony Park Dr.
North Bethesda,  MD  20852
Applicant Contact N. T. UMAMAHESWARAN
Correspondent
Bu Polysciences Equipment & Trading, LLC
10855 Symphony Park Dr.
North Bethesda,  MD  20852
Correspondent Contact N. T. UMAMAHESWARAN
Classification Product Code
FRO  
Date Received10/30/2015
Decision Date 06/23/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-