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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoes, Operating-Room
510(k) Number K923187
Device Name IMPERVIOUS ISOLATION SHOE COVERS
Applicant
Dynatech Medical Products
605 White Hills Dr.
Rockwall,  TX  75087
Applicant Contact MITCHELL DAVIS
Correspondent
Dynatech Medical Products
605 White Hills Dr.
Rockwall,  TX  75087
Correspondent Contact MITCHELL DAVIS
Regulation Number878.4040
Classification Product Code
FXW  
Date Received06/30/1992
Decision Date 01/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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