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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 K910735
Device Name HEXIDIS ALCOHOL SWAB
Applicant
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact PETER S REICHERTZ
Classification Product Code
LKB  
Date Received02/21/1991
Decision Date 04/02/1991
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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