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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K911606
Device Name BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
Applicant
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Applicant Contact STEPHEN A CAMPBELL
Correspondent
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Correspondent Contact STEPHEN A CAMPBELL
Regulation Number878.4800
Classification Product Code
KDD  
Date Received04/10/1991
Decision Date 07/09/1991
Decision Substantially Equivalent - Kit (SESK)
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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