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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Razor, Surgical
510(k) Number K910524
Device Name SURGICAL CLIPPER
Applicant
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355 -8900
Applicant Contact STEPHEN A CAMPBELL
Correspondent
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355 -8900
Correspondent Contact STEPHEN A CAMPBELL
Regulation Number878.4800
Classification Product Code
LWK  
Date Received02/07/1991
Decision Date 03/28/1991
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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