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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K102783
Device Name HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
Applicant
Hinson and Hale Medical Technologies, Inc.
7809 Adelaide Dr.
Austin,  TX  78739
Applicant Contact JEFFREY O STULL
Correspondent
Hinson and Hale Medical Technologies, Inc.
7809 Adelaide Dr.
Austin,  TX  78739
Correspondent Contact JEFFREY O STULL
Regulation Number880.6850
Classification Product Code
FRG  
Date Received09/27/2010
Decision Date 12/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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