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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 K884417
Device Name SURGEON'S GLOVE ACCESSORY
Applicant
Allied Signal, Inc.
Law Dept.
P.O. Box 2245r
Morristown,  NJ  07960
Applicant Contact PATRICK L HENRY
Correspondent
Allied Signal, Inc.
Law Dept.
P.O. Box 2245r
Morristown,  NJ  07960
Correspondent Contact PATRICK L HENRY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/20/1988
Decision Date 12/09/1988
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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