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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 K945267
Device Name OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
Applicant
Optus, Inc.
1200 S. Parker Rd.
Denver,  CO  80231
Applicant Contact PETER DUFFY
Correspondent
Optus, Inc.
1200 S. Parker Rd.
Denver,  CO  80231
Correspondent Contact PETER DUFFY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/28/1994
Decision Date 05/23/1995
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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