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 Neurological Stereotaxic Instrument
510(k) Number K012380
Device Name MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
Applicant
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact ROBIN L ROWE
Correspondent
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact ROBIN L ROWE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/26/2001
Decision Date 12/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-