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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Nonpowered
510(k) Number K870767
Device Name THE (CROM) TESTER
Applicant
Twin City Surgical, Inc.
2800 N.Fairview Ave.
St. Paul,  MN  55113
Applicant Contact WAYNE O DUESCHER
Correspondent
Twin City Surgical, Inc.
2800 N.Fairview Ave.
St. Paul,  MN  55113
Correspondent Contact WAYNE O DUESCHER
Regulation Number888.1520
Classification Product Code
KQW  
Date Received02/26/1987
Decision Date 03/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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