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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K140289
Device Name INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
Applicant
SUMMIT MEDICAL, INC.
815 NORTHWEST PKWY, STE 100
ST. PAUL,  MN  55121
Applicant Contact NICOLE DOVE
Correspondent
SUMMIT MEDICAL, INC.
815 NORTHWEST PKWY, STE 100
ST. PAUL,  MN  55121
Correspondent Contact NICOLE DOVE
Regulation Number880.6850
Classification Product Code
KCT  
Date Received02/05/2014
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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