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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K023449
Device Name NON-INVASIVE PATIENT FIXATION SYSTEM
Applicant
Stryker Leibinger
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact KELLI J BITTERBURG
Correspondent
Stryker Leibinger
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact KELLI J BITTERBURG
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/15/2002
Decision Date 01/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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