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 Container, Sharps
510(k) Number K063666
Device Name SHARPS CONTAINER, MODEL 039-413
Applicant
Biodex Medical Systems, Inc.
20 Ramsay Rd.
Shirley,  NY  11967
Applicant Contact CLYDE SCHLEIN
Correspondent
Biodex Medical Systems, Inc.
20 Ramsay Rd.
Shirley,  NY  11967
Correspondent Contact CLYDE SCHLEIN
Regulation Number880.5570
Classification Product Code
MMK  
Date Received12/11/2006
Decision Date 01/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-