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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 K092682
Device Name GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS
Applicant
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Applicant Contact LORRAINE CALZETTA
Correspondent
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact LORRAINE CALZETTA
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/01/2009
Decision Date 12/11/2009
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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