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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 K885099
Device Name MULTIPLE (STERILE SURGICAL TOWELS)
Applicant
MED-TEX, INC.
17 GATEWAY RD.
BENSENVILLE,  IL  60106
Applicant Contact SHAN PADDA
Correspondent
MED-TEX, INC.
17 GATEWAY RD.
BENSENVILLE,  IL  60106
Correspondent Contact SHAN PADDA
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/12/1988
Decision Date 03/22/1989
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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