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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 K071783
Device Name VERSAPOD (TM) INSTRUMENT TRAYS
Applicant
Containmed, Inc.
1404 Main St.
Speedway,  IN  46224
Applicant Contact TODD E BETTENHAUSEN
Correspondent
Containmed, Inc.
1404 Main St.
Speedway,  IN  46224
Correspondent Contact TODD E BETTENHAUSEN
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/02/2007
Decision Date 09/09/2008
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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