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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 K110377
Device Name PROTECTIVE RESTRAINT
Applicant
Medi-Tech Intl. Corp.
26 Court St., Suite 1301
Brooklyn,  NY  11242
Applicant Contact MARILYN GEIGER
Correspondent
Medi-Tech Intl. Corp.
26 Court St., Suite 1301
Brooklyn,  NY  11242
Correspondent Contact MARILYN GEIGER
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received02/09/2011
Decision Date 04/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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