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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Alcohol, Device Disinfectant
510(k) Number K894791
Device Name BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE
Applicant
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Applicant Contact WANDA TOTTON
Correspondent
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Correspondent Contact WANDA TOTTON
Classification Product Code
LKB  
Date Received07/28/1989
Decision Date 10/03/1989
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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