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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Arthroscope
510(k) Number K946290
Device Name CITATION POWER TOOL
Applicant
Citation Medical Corp.
230 Edison Way
Reno,  NV  89502
Applicant Contact ROGER KRIEIDBERG
Correspondent
Citation Medical Corp.
230 Edison Way
Reno,  NV  89502
Correspondent Contact ROGER KRIEIDBERG
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/27/1994
Decision Date 06/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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