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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K942758
Device Name HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE
Applicant
Aladan Corp.
2926 Columbia Hwy.
P.O. Box 8308
Dotham,  AL  36303
Applicant Contact NEIL ANDERSON
Correspondent
Aladan Corp.
2926 Columbia Hwy.
P.O. Box 8308
Dotham,  AL  36303
Correspondent Contact NEIL ANDERSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/13/1994
Decision Date 07/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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