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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K000349
Device Name MOTORIZED MICRO MULTILEAF COLLIMATOR
Applicant
Stryker Leibinger
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact KRISTYN R KELLEY
Correspondent
Stryker Leibinger
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact KRISTYN R KELLEY
Regulation Number892.5710
Classification Product Code
IXI  
Date Received02/03/2000
Decision Date 05/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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