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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 K030853
Device Name STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI
Applicant
CASE MEDICAL, INC.
65 RAILROAD AVE.
RIDGEFIELD,  NJ  07657 -0402
Applicant Contact MARCIA FRIEZE
Correspondent
CASE MEDICAL, INC.
65 RAILROAD AVE.
RIDGEFIELD,  NJ  07657 -0402
Correspondent Contact Tania Lupu
Regulation Number880.6850
Classification Product Code
FRG  
Date Received03/18/2003
Decision Date 03/21/2003
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
Recalls CDRH Recalls
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