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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 K860961
Device Name GAMMA RADIATION STERILIZED ALCOHOL PREP PADS
Applicant
H & P Industries, Inc.
9640 S 60th St.
Franklin,  WI  53132
Applicant Contact JOSEPH DUNN
Correspondent
H & P Industries, Inc.
9640 S 60th St.
Franklin,  WI  53132
Correspondent Contact JOSEPH DUNN
Classification Product Code
LKB  
Date Received03/13/1986
Decision Date 04/09/1986
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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