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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 K110500
Device Name STAT-MAT MINOR
Applicant
MACPHERSON MEDICAL, INC.
555 13TH STREET, NW
COLUMBIA SQUARE
WASHINGTON,  DC  20004
Applicant Contact HOWARD HOLSTEIN
Correspondent
MACPHERSON MEDICAL, INC.
555 13TH STREET, NW
COLUMBIA SQUARE
WASHINGTON,  DC  20004
Correspondent Contact HOWARD HOLSTEIN
Regulation Number880.6850
Classification Product Code
KCT  
Date Received02/22/2011
Decision Date 06/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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