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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Skin Prep Tray
510(k) Number K781797
Device Name PREP TRAY, PREOPERATIVE SKIN
Applicant
Pharmaseal Div., Baxter Healthcare Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pharmaseal Div., Baxter Healthcare Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
OJU  
Date Received10/23/1978
Decision Date 11/08/1978
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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