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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Non-Measuring
510(k) Number K781350
Device Name OBJECTS PRECISION HANDLING TEST KIT
Applicant
Metro. Hospital & Health Center
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Metro. Hospital & Health Center
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5370
Classification Product Code
ION  
Date Received08/07/1978
Decision Date 10/17/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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