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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 K051157
Device Name INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
Applicant
MICROMEDICS, INC.
1270 EAGAN INDUSTRIAL ROAD
SUITE 120
EAGAN,  MN  55121
Applicant Contact TOM A LOPAC
Correspondent
MICROMEDICS, INC.
1270 EAGAN INDUSTRIAL ROAD
SUITE 120
EAGAN,  MN  55121
Correspondent Contact TOM A LOPAC
Regulation Number880.6850
Classification Product Code
KCT  
Date Received05/05/2005
Decision Date 09/01/2005
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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