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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Dowel Cutting
510(k) Number K893874
Device Name FUJITENS III
Applicant
Altoona Medical Supply
705 2nd Ave., SW
Altoona,  IA  50009
Applicant Contact DONALD MACKENZIE
Correspondent
Altoona Medical Supply
705 2nd Ave., SW
Altoona,  IA  50009
Correspondent Contact DONALD MACKENZIE
Regulation Number882.4275
Classification Product Code
GZQ  
Date Received05/26/1989
Decision Date 12/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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