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 Cement Obturator
510(k) Number K943727
Device Name BIOSTOP G BONE CEMENT RESTRICTOR
Applicant
Landos, Inc.
Suite 1, 301 Lindenwood Dr.
Office 26
Malvern,  PA  19355
Applicant Contact JEROME VERON
Correspondent
Landos, Inc.
Suite 1, 301 Lindenwood Dr.
Office 26
Malvern,  PA  19355
Correspondent Contact JEROME VERON
Regulation Number878.3300
Classification Product Code
LZN  
Subsequent Product Code
JDK  
Date Received08/02/1994
Decision Date 05/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-