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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K094016
Device Name NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H
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 Number878.4370
Classification Product Code
KKX  
Date Received12/29/2009
Decision Date 11/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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