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510(k) K950995

Device
SENSICARE SYNTHETIC, SURGICAL GLOVE LINER
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K950995
Product code
LYN  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-28
Date received
1995-03-03
Regulation
874.1050
Classification name
Apparatus, Visual Reinforcement Audiometric
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EDWARD ROSEN
Address
One Becton Dr. Franklin Lake NJ US 07417 07417

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LYN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K897143VERA 103Madsen North America, Inc.1990-04-27
K880259VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADVColorado Hearing Systems, Inc.1989-04-03

Legacy Summary#

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FDA Review#

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