STRYKER NAVIGATION SYSTEM – ENT MODULE


Device Classification Name

neurological stereotaxic instrument

510(k) Number K002732
Device Name STRYKER NAVIGATION SYSTEM – ENT MODULE
Original Applicant
STRYKER CORP.
4100 east milham ave.
kalamazoo, 
MI 
49001 -6197

Original Contact nicole petty
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 09/01/2000
Decision Date 10/02/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No