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 Instrument, Biopsy
510(k) Number K954151
Device Name BIOACCESS BONE BIOPSY 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 Number876.1075
Classification Product Code
KNW  
Date Received09/05/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-