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 Staple, Implantable
510(k) Number K141367
Device Name LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS
Applicant
Touchstone International Medical Science Co., Ltd.
21a Science Plaza, Intrenational Science Park #1355
Jinjihu Ave.
Suzhou, Jiangsu,  CN 215021
Applicant Contact JO QIAO
Correspondent
Touchstone International Medical Science Co., Ltd.
21a Science Plaza, Intrenational Science Park #1355
Jinjihu Ave.
Suzhou, Jiangsu,  CN 215021
Correspondent Contact JO QIAO
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received05/23/2014
Decision Date 07/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-