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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K841583
Device Name SPORSTRIP
Applicant
SKYLAND SCIENTIFIC SERVICES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SKYLAND SCIENTIFIC SERVICES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2800
Classification Product Code
FRC  
Date Received04/17/1984
Decision Date 05/25/1984
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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