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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 K102103
Device Name SKELETAL DYNAMICS STERILIZATION TRAYS
Applicant
Skeletal Dynamics, LLC
8905 SW 87 Ave., Suite 201
Miami,  FL  33176
Applicant Contact ANA M ESCAGEDO
Correspondent
Skeletal Dynamics, LLC
8905 SW 87 Ave., Suite 201
Miami,  FL  33176
Correspondent Contact ANA M ESCAGEDO
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/27/2010
Decision Date 12/07/2010
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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