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 suture, nonabsorbable, synthetic, polyethylene
510(k) Number K094028
Device Name CP-FIBER (ORTHOFIBER)
Applicant
CP MEDICAL
803 NE 25TH AVE.
PORTLAND,  OR  97232
Applicant Contact BARBARA K HORTON
Correspondent
CP MEDICAL
803 NE 25TH AVE.
PORTLAND,  OR  97232
Correspondent Contact BARBARA K HORTON
Regulation Number878.5000
Classification Product Code
GAT  
Date Received12/30/2009
Decision Date 03/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-