• 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
510(k) Number K863034
Device Name SHARPOINT STAINLESS STEEL SUTURE
Applicant
CHATHAMBOROUGH RESEARCH GROUP, INC.
105 WEST ST.
P.O. BOX DRAWER 929
PITTSBORO,  NC  27312
Applicant Contact TIM HUBBARD
Correspondent
CHATHAMBOROUGH RESEARCH GROUP, INC.
105 WEST ST.
P.O. BOX DRAWER 929
PITTSBORO,  NC  27312
Correspondent Contact TIM HUBBARD
Regulation Number878.4495
Classification Product Code
GAO  
Date Received08/11/1986
Decision Date 09/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-