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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 K953776
FOIA Releasable 510(k) K953776
Device Name STERIKING STERILIZATION POUCHES & ROLLS
Applicant
Wihuri OY
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
Wihuri OY
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number880.6850
Classification Product Code
KCT  
Date Received08/11/1995
Decision Date 10/12/1995
Decision Substantially Equivalent (SESE)
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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