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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K963552
Device Name QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
Applicant
Tecnol Medical Products, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Applicant Contact RUTH L JONES
Correspondent
Tecnol Medical Products, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Correspondent Contact RUTH L JONES
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/05/1996
Decision Date 11/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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