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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K791738
Device Name CUSTOM DRESSING CHANGE TRAYS
Applicant
Sterile Design, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sterile Design, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6250
Classification Product Code
FMC  
Date Received08/30/1979
Decision Date 10/02/1979
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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