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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Drill, Ligament
510(k) Number K854254
Device Name TENSION-ISOMETER
Applicant
Medmetric Corp.
4901 Morena Blvd.
Suite 322
San Diego,  CA  92117
Applicant Contact WATKINS
Correspondent
Medmetric Corp.
4901 Morena Blvd.
Suite 322
San Diego,  CA  92117
Correspondent Contact WATKINS
Regulation Number878.4820
Classification Product Code
LXI  
Date Received10/22/1985
Decision Date 11/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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