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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, Antimicrobial
510(k) Number K905803
Device Name HALE SUN SURGICAL TOWEL OR O.R. TOWEL
Applicant
Hale Sun Industries, Ltd.
One Richmond Squar
Providence,  RI  02906
Applicant Contact LOCKETT III
Correspondent
Hale Sun Industries, Ltd.
One Richmond Squar
Providence,  RI  02906
Correspondent Contact LOCKETT III
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/28/1990
Decision Date 05/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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