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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K914763
Device Name DERMACARE SYNTHETIC MEDICAL GLOVE
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact J ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact J ARNSBERGER
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/22/1991
Decision Date 02/07/1992
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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