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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 K972123
Device Name PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
Applicant
Smith
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Smith
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received06/05/1997
Decision Date 07/25/1997
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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