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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Adhesive, Aerosol
510(k) Number K851612
Device Name DERMA PREP
Applicant
Mowbray Co., Inc.
720 Broadway
Waterloo,  IA  50703
Applicant Contact JERRY S PIETERS
Correspondent
Mowbray Co., Inc.
720 Broadway
Waterloo,  IA  50703
Correspondent Contact JERRY S PIETERS
Regulation Number878.4380
Classification Product Code
KGT  
Date Received04/18/1985
Decision Date 05/03/1985
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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