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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Powered
510(k) Number K904950
Device Name MANUAL AND MOTORIZED FLEXION DISTRACTION TABLES
Applicant
Leander Research, Mfg & Distr., Inc.
12300 SW Sidney Rd.
Port Orchard,  WA  98367
Applicant Contact CHARLES R JONES
Correspondent
Leander Research, Mfg & Distr., Inc.
12300 SW Sidney Rd.
Port Orchard,  WA  98367
Correspondent Contact CHARLES R JONES
Regulation Number890.3760
Classification Product Code
INQ  
Date Received11/02/1990
Decision Date 11/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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