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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K861554
Device Name PORT-A-TRAC
Applicant
Port-A-Trac Co.
Calder Square
P. O. Box 10192
State College,  PA  16805
Applicant Contact RONNIE C HESS
Correspondent
Port-A-Trac Co.
Calder Square
P. O. Box 10192
State College,  PA  16805
Correspondent Contact RONNIE C HESS
Regulation Number890.5880
Classification Product Code
JFB  
Date Received04/25/1986
Decision Date 06/19/1986
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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