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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 K991023
Device Name STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL
Applicant
Case Medical, Inc.
1900 K St. NW
Washington,  DC  20006 -1108
Applicant Contact LARRY R PILOT
Correspondent
Case Medical, Inc.
1900 K St. NW
Washington,  DC  20006 -1108
Correspondent Contact Tania Lupu
Regulation Number880.6850
Classification Product Code
FRG  
Date Received03/29/1999
Decision Date 01/27/2000
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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