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 component, traction, invasive
510(k) Number K915800
Device Name BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
Applicant
BREMER MEDICAL, INC.
C/O HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
BREMER MEDICAL, INC.
C/O HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number888.3040
Classification Product Code
JEC  
Date Received12/24/1991
Decision Date 03/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-