• 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 suture, nonabsorbable, synthetic, polypropylene
510(k) Number K113763
Models 08-15-11, 08-15-11GW
Device Name SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
Original Applicant
NOBLES MEDICAL TECHNOLOGIES II, INC.
17080 newhope st
fountain valley,  CA  92708
Original Contact maria hategan
Regulation Number878.5010
Classification Product Code
GAW  
Date Received12/21/2011
Decision Date 03/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-