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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Skin Pressure
510(k) Number K761268
Device Name SKIN PRESSURE PROTECTORS
Applicant
Mark One Healthcare Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mark One Healthcare Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6450
Classification Product Code
FMP  
Date Received12/16/1976
Decision Date 02/16/1977
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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