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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 K924494
Device Name CITSCOPE, BENDABLE -- MODIFICATION
Applicant
Citation Medical Corp.
230 Edison Way
Reno,  NV  89502
Applicant Contact EDWARD F WADDELL
Correspondent
Citation Medical Corp.
230 Edison Way
Reno,  NV  89502
Correspondent Contact EDWARD F WADDELL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/27/1992
Decision Date 05/26/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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