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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spoon, Ear
510(k) Number K884483
Device Name CRUCIOMETER
Applicant
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Applicant Contact ROBERT R MOORE
Correspondent
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Correspondent Contact ROBERT R MOORE
Regulation Number874.4420
Classification Product Code
JZE  
Date Received10/25/1988
Decision Date 01/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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