• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name plate, fixation, bone
510(k) Number K052041
Device Name COLLAGEN BONE HEALING PROTECTIVE SHEET
Original Applicant
COLLAGEN MATRIX, INC.
509 commerce st.
franklin lakes,,  NJ  07417
Original Contact peggy hansen
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
FTM   LZN  
Date Received07/29/2005
Decision Date 10/25/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-