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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K930026
Device Name POLY-MED DISPOSABLE PERSONAL PROTECTION KIT
Applicant
Medtek Development Corp.
1917 E. Taylor St.
Bloomington,  IL  61701
Applicant Contact WILLIAM B SMITH
Correspondent
Medtek Development Corp.
1917 E. Taylor St.
Bloomington,  IL  61701
Correspondent Contact WILLIAM B SMITH
Regulation Number878.4040
Classification Product Code
FYC  
Date Received01/05/1993
Decision Date 10/04/1993
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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