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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 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
Applicant Contact STEPHEN A CAMPBELL
Correspondent
BAXTER HEALTHCARE CORP.
27200 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
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
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