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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 K896835
Device Name ALCOHOL PREP AND POVIDONE-IODINE PREP
Applicant
Norpak Mfg., Inc.
85 Chambers Dr., #8
Ajax, Ontario L1z 1e2,  CA
Applicant Contact MICHAEL CRUICKSHANK
Correspondent
Norpak Mfg., Inc.
85 Chambers Dr., #8
Ajax, Ontario L1z 1e2,  CA
Correspondent Contact MICHAEL CRUICKSHANK
Classification Product Code
LKB  
Date Received12/05/1989
Decision Date 01/11/1990
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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