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 Tube, Collection, Capillary Blood
510(k) Number K941291
Device Name MONOJECT SAMPLETTE SEPARATOR TUBE
Applicant
Sherwood Medical Co.
1831 Olive St.
St.Louis,  MO  63103
Applicant Contact DENNIS POZZO
Correspondent
Sherwood Medical Co.
1831 Olive St.
St.Louis,  MO  63103
Correspondent Contact DENNIS POZZO
Regulation Number864.6150
Classification Product Code
GIO  
Date Received03/17/1994
Decision Date 10/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-