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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
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