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 needle, aspiration and injection, reusable
510(k) Number K923872
Device Name BONE MARROW BIOPSY SYSTEM
Applicant
THE STRAUMANN CO.
ONE ALEWIFE CENTER
CAMBRIDGE,  MA  02140 -2317
Applicant Contact CAROLYN BITETTI
Correspondent
THE STRAUMANN CO.
ONE ALEWIFE CENTER
CAMBRIDGE,  MA  02140 -2317
Correspondent Contact CAROLYN BITETTI
Regulation Number878.4800
Classification Product Code
GDM  
Date Received08/03/1992
Decision Date 12/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-