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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 K033222
Device Name OLYMPUS STERILIZATION TRAYS
Applicant
Olympus Winter & Ibe GmbH
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact TINA STEFFANIE-OAK
Correspondent
Olympus Winter & Ibe GmbH
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact TINA STEFFANIE-OAK
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/03/2003
Decision Date 08/02/2004
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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