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 Laparoscope, General & Plastic Surgery
510(k) Number K120012
Device Name INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
Applicant
Integra LifeSciences Corporation
589 Davies Dr.
York,  PA  17402
Applicant Contact STEPHANIE SHEESLEY
Correspondent
Integra LifeSciences Corporation
589 Davies Dr.
York,  PA  17402
Correspondent Contact STEPHANIE SHEESLEY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/03/2012
Decision Date 09/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-