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 centrifuges (micro, ultra, refrigerated) for clinical use
510(k) Number K071934
Device Name MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
WARSAW,  IN  46582
Applicant Contact MARY L VERSTYNEN
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
WARSAW,  IN  46582
Correspondent Contact MARY L VERSTYNEN
Regulation Number862.2050
Classification Product Code
JQC  
Date Received07/13/2007
Decision Date 10/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-