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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 K870718
Device Name AMERICAN ALCOHOL PREP PAD STERILE MEDIUM
Applicant
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Applicant Contact CHARLES B MITCHELL
Correspondent
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Correspondent Contact CHARLES B MITCHELL
Classification Product Code
LKB  
Date Received02/20/1987
Decision Date 05/07/1987
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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