• 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 K971114
Device Name BIOACCESS MARROW HARVEST SYSTEM
Applicant
BIOACCESS, INC.
8400 CEDAR ST.
SILVER SPRING,  MD  20910
Applicant Contact PETER J CARNES
Correspondent
BIOACCESS, INC.
8400 CEDAR ST.
SILVER SPRING,  MD  20910
Correspondent Contact PETER J CARNES
Regulation Number878.4800
Classification Product Code
GDM  
Date Received03/26/1997
Decision Date 06/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-