• 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 Needle, Hypodermic, Single Lumen
510(k) Number K965248
Device Name BEMIS TWO GALLON SHARPS CONTAINER
Applicant
BEMIS MFG. CO.
300 MILL ST.
SHEBOYGAN FALLS,  WI  53085
Applicant Contact JOHN B HOWELL
Correspondent
BEMIS MFG. CO.
300 MILL ST.
SHEBOYGAN FALLS,  WI  53085
Correspondent Contact JOHN B HOWELL
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/04/1996
Decision Date 02/14/1997
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
Recalls CDRH Recalls
-
-