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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vein Location, Liquid Crystal
510(k) Number K780884
Device Name HYPO-GRIP
Applicant
Harco Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Harco Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6970
Classification Product Code
KZA  
Date Received05/30/1978
Decision Date 08/10/1978
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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