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 K142603
Device Name Stryker Precision HD Camera System
Applicant
Stryker Endoscopy
5900 Optical Court
San Jose,  CA  95138
Applicant Contact Angela Wong
Correspondent
THIRD PARTY REVIEW GROUP, LLC
45 ROCKEFELLER PLAZA
SUITE 2000
NEW YORK,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/15/2014
Decision Date 10/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-