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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K943653
Device Name MAMMOCORE BIOPSY TRAY
Applicant
Manan Medical Products, Inc.
2200 Carlson Dr.
Northbrook,  IL  60062
Applicant Contact FRED MITTERMEIER
Correspondent
Manan Medical Products, Inc.
2200 Carlson Dr.
Northbrook,  IL  60062
Correspondent Contact FRED MITTERMEIER
Regulation Number880.6850
Classification Product Code
FRG  
Date Received07/28/1994
Decision Date 01/30/1995
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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