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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 STREET, N.W.
WASHINGTON,  DC  20006 -1108
Applicant Contact LARRY R PILOT
Correspondent
CASE MEDICAL, INC.
1900 K STREET, N.W.
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
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