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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 K971948
Device Name PATIENT RESTRAINT
Applicant
E.M. ADAMS CO., INC.
7496 COMMERCIAL CIRCLE
FORT PIERCE,  FL  34951
Applicant Contact RICHARD K DONAHUE
Correspondent
E.M. ADAMS CO., INC.
7496 COMMERCIAL CIRCLE
FORT PIERCE,  FL  34951
Correspondent Contact RICHARD K DONAHUE
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received05/28/1997
Decision Date 08/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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