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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854809
Device Name WHITE CROSS STERILE PAD 4IN. X 4IN.
Applicant
American White Cross, Inc.
Box L
New Rochelle,  NY  10802
Applicant Contact JACK ORENTZEL
Correspondent
American White Cross, Inc.
Box L
New Rochelle,  NY  10802
Correspondent Contact JACK ORENTZEL
Date Received12/03/1985
Decision Date 01/13/1986
Decision Substantially Equivalent (SESE)
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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