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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 K921985
Device Name ARTHROSCOPE & ACCESSORIES
Applicant
Optimed Technologies, Inc.
1441 N. Batavia St.T,
Suite 114
Orange,  CA  92667
Applicant Contact RONALD J EHMSEN
Correspondent
Optimed Technologies, Inc.
1441 N. Batavia St.T,
Suite 114
Orange,  CA  92667
Correspondent Contact RONALD J EHMSEN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/28/1992
Decision Date 06/29/1993
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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