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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Visual Reinforcement Audiometric
510(k) Number K950995
Device Name SENSICARE SYNTHETIC, SURGICAL GLOVE LINER
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact EDWARD ROSEN
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact EDWARD ROSEN
Regulation Number874.1050
Classification Product Code
LYN  
Date Received03/03/1995
Decision Date 06/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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