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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Non-Invasive
510(k) Number K854270
Device Name MURPHY ADJUSTABLE SPLINT
Applicant
Comfortex, Inc.
420 Main St.
Winona,  MN  55987
Applicant Contact DONALD M SALYARDS
Correspondent
Comfortex, Inc.
420 Main St.
Winona,  MN  55987
Correspondent Contact DONALD M SALYARDS
Regulation Number888.5890
Classification Product Code
KQZ  
Date Received10/23/1985
Decision Date 12/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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